MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, during intraocular lens implantation surgery, the posterior capsule ruptured when implanting the lens.Hence the lens was removed and replaced with another lens during the same surgery.There was no patient harm.Additional information has been received stating that, it was a polar cataract with a thin layer of capsule, upon injecting the lens, the thin capsule torn.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was returned wrapped in folded white gauze material taped close and placed inside the lens carton.Viscoelastic was dried on the lens.The lens was cleaned with klrp for further evaluation.There was no haptic or optic damage observed to the lens.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were used.The product investigation could not identify a root cause for the reported complaint.The returned lens was evaluated.There was no damage observed to the lens.The lens was dimensionally acceptable using an approved template.Qualified associated products were used.Follow up information stated that "this case was a polar cataract with a thin layer of capsule, upon injecting the lens, the thin capsule torn".This information may suggest that the rupture was unrelated to the intra ocular lens (iol).A polar cataract is a rare type of cataract that forms on the back of the eye's lens, at the posterior pole, often present at birth but can develop later in life.Surgery for polar cataracts can be challenging due to potential for posterior capsule rupture during the procedure because the membrane surrounding the natural lens can be fragile.The 22.5 diopter lens was removed and replaced with another lens (diopter unknown).File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22063762
• Report Number: 1119421-2025-01454
• Device Sequence Number: 8348153
• Product Code: HQL
• UDI-Device Identifier: 00380652332712
• UDI-Public: (01)00380652332712(17)290413(11)240415(10)15838855
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.225
• Device Lot Number: 15838855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTERIOR CHAMBER PMMA IOL; DISCOVISC; MONARCH III INJECTOR; MONARCH III CARTRIDGE D
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female