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RecallWatchMedical Device Safety
Class IIOngoingZ-0835-2025

Alcon Research LLC recalls Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Numbe…

Alcon Research LLCFort Worth, TX, United StatesReported Jan 22, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component:N/A
    UDI 10380659777636/
    336 affected lots
    1589592715895928158959291589593015895931158959321589593315895934
    +328 more15895935158959361589593715895938158959391589594015895941158959421589596515895969158959731589597715899643158996441589968715899688158996891589969015899691158996921589969315899695158996961589969715899698158997001589970115899730158997311589973215899733158997341589973515899736158997371589973815899753159040261590402715904028159040291590403015904031159040321590403315904034159040351590403615904037159040381590403915904040159040411590404215904043159040451590685115906852159068531591383215913833159138341591383515913836159138371591383815913839159138401591384115913842159138461591385015913855159138591591386215913919159139201591392115913922159139231591392415913925159139261591392715913928159139291591393015913931159139321591393315913934159139351591393615913937159139381591393915913940159139411591394215913943159139441591394515913946159139471591394815913949159139501591395115913952159139531591395415913955159139561591395715913958159139591591396115914064159140651591406615914067159140681591406915914119159141201591412115914123159141241591412615914128159290381592903915929040159290411592904215929044159290451592919815929199159292001592920115929202159292031592920415929205159292061592920715929208159292091592921015929211159292121592921315929214159292151592921615929217159292181592921915929220159292211592922215929223159292241592922515929226159292271592922815929229159292301592923115929232159292331592923415929235159292361592923715929238159292651592928515932682159326831593268415932685159326861593268715932688159326891593269015932691159326921593269315932694159326951593269615932697159326981593269915932700159327011593270215932703159327041593270515932706159327071593270815932709159327101593271115932712159327131593271515932716159327181593272015933058159330591593306015933061159330621593306315933064159330651593306615933067159330681593306915933070159330711593307215933073159330741593307515933076159330781593309115933092159330931593309415933095159330961593309715933098159330991593310015933101159331021593310315933104159331051593310615933107159331081593310915933110159331121593317215933173159331741593317515933176159331771593324315933244159332451593324615933247159332481593324915933250159332511593325215933253159332541593325515933256159332571593326015933261159332621593326315933264159332651593326615933267159332681593326915933270159332711593327215933273159332741593327515933276159332771593327815933281159333501593335115933352159333531593335415933355159333561593335715933358159333591593336015933361159333621593336315933364159333651593336615933367159445301594453115944532159445341594453515950090159500911595009215950093159500941595009515950096

What the firm is doing

On 11/13/2024, Alcon Laboratories, Inc. issued a "Urgent: Medical Device Field Correction" to affected consignees. Alcon asked consignees to take the following actions: 1. See Table 1 for list of affected of Monarch III D delivery cartridges distributed to your facility. 2. Review your Monarch III D delivery cartridge inventory to determine if you have any remaining units from the identified lots. 3. If you have remaining units from the identified lots, please dispose of all impacted lots of Monarch III D delivery cartridges identified in Table 1. Please contact Alcon Customer Service to arrange for replacement of Monarch III D delivery cartridges. 4. Please confirm quantity destroyed by including on response form, even if you have zero units remaining in inventory. 5. Forward this notification to professionals within your organization who may be using the identified of Monarch III D delivery cartridges, and to all departments or organizations to which identified lots of Monarch III D delivery cartridges lots may have been transferred. 6. Respond to Alcon indicating your understanding of the included instructions by completing our online response form at https://qrco.de/Monarch-Response or by completing the attached Response Form and returning to Alcon via email or fax. 7. In the event you have experienced adverse events or product quality issues related to this communication, please contact Alcon via web (https://notifeye.alcon.com), by email (msus.safety@alcon.com) or by phone (1-800-757-9780) Monday through Friday, 8:00 AM to 5:00 PM, Central Time. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA MedWatch Adverse Event Reporting program: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

DistributionShow details

US: AK AL AR AZ CA CO CT DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY OUS: Russia, Egypt

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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