MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.The complainant indicates the use of company cartridge and non company viscoelastic.Both of these accessories are not qualified for use with the associated iol model.We are unable to verify the reported complaint.No sample was returned for evaluation.The root cause may be related to failure to follow ifu, as the surgeon states the use of non-qualified combination and non-qualified ovd.The use of an non-qualified combination or non-qualified ovd may cause damage to the iol and potential complications during the implantation process.Based on the results from the product history record, the products met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during implantation of intraocular lens (iol), rupture of the capsule by the lens was noted.Due to unstability of the lens with the haptics, the lens was explanted and replaced by 3 piece lens.
Additional Manufacturer Narrative
The product was returned for analysis.Iol returned positioned incorrectly in the iol case.Solution is dried on both surfaces of the optic and haptics.One haptic is intact, the other has fibers and marks from an indelible marker.The optic the optic is cracked/fractured and scratched/marked-rejectable with loose fibers, particulate and marks from an indelible marker.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15368747
• Report Number: 9612169-2022-00440
• Device Sequence Number: 15100473
• Product Code: HQL
• UDI-Device Identifier: 00380652555777
• UDI-Public: 00380652555777
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: SA60AT
• Device Catalogue Number: SA60AT.185
• Device Lot Number: 25348396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: BIOVISC, LOT NUMBER: 4024381; MONARCH III IOL CARTRIDGE D
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown