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

Model Number	SA60WF
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported during the intraocular lens implantation the lens was faulty, melted and deformed as a result it could not be used.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints for the reported lot.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints for the reported lot.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported during the intraocular lens implantation the lens was faulty, melted and deformed as a result it could not be used.Additional information has been requested.
Event or Problem Description
Additional information has been received and stated that, the lens was faulty, melted and deformed was found before the surgery started.There was no patient contact noted.Based on information received following submission of the previous report, this event does not meet criteria for reporting as a malfunction.
Additional Manufacturer Narrative
Based on information received following submission of the previous report, this event does not meet criteria for reporting as a malfunction.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and the reported damage was observed.Iol returned pressed down on two(2) posts of the lens case base resulting in gross optic and haptic damage.Solution is dried on both surfaces of the optic and one haptic.One haptic is deformed and has haptic tip damage rejectable, the other haptic is nicked/chipped-rejectable.The optic is deformed, scratched rejectable.We are unable to determine the root cause for the reported complaint - "fault on the lens, lens is melted and deformed".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and one haptic.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.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 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: 13560135
• Report Number: 9612169-2022-00076
• Device Sequence Number: 17110786
• Product Code: HQL
• UDI-Device Identifier: 00380652332682
• UDI-Public: 00380652332682
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.210
• Device Lot Number: 25273659
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 06/02/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/07/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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
• Patient Sex: Unknown