MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis; it remains implanted.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A patient reported that following a cataract extraction with intraocular lens (iol) implant procedure, the vision was terrible, everything was wavy.The patient was told she had an epiretinal membrane macular pucker, and that it could only be cured by surgery that is considered risky.Approximately 2 years later the patient reported that she could not see out of the eye where the cataract was removed.She was sent to see a retina specialist, but the doctor was not sure what had happened.She was sent to a hospital for an angiogram of her eye.The diagnosis was an epiretinal membrane but the patient believes there was some doubt.She can see fairly well with both eyes open.When she closes the fellow eye, she cannot see well enough to read or much else.A straight line is now wavy and letters jump up and down.Further information provided by the patient that the eye wasn't good as soon as she left surgery.

• 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
• MDR Report Key: 11800968
• Report Number: 9612169-2021-00115
• Device Sequence Number: 1020453
• Product Code: HQL
• UDI-Device Identifier: 00380652332699
• UDI-Public: 00380652332699
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: No Information
• Device Expiration Date: 07/31/2021
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.215
• Device Lot Number: 21169430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR