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

Model Number	SN60AT
Medical Device Problem Codes	Material Opacification (1426); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: 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).
Event or Problem Description
A customer reported having 'more and more problems' with glistenings on intraocular lenses (iols).Additional information was requested and received reporting an prk procedure was performed.
Event or Problem Description
Additional information received from the patient stating she will not do an additional examination because of the additional costs.She consulted dr.(b)(6) just once.The implantation was performed by dr.(b)(6).
Additional Manufacturer Narrative
The manufacturer internal reference number is:(b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received indicated that following implantation of the iols, " i saw everything small with one eye and everything big with the other" therefore, photorefractive keratectomy (prk) was performed.Dry eyes, artificial light from above and strange vision problems have been present since the procedure.This report is for the right eye.
Additional Manufacturer Narrative
The product was not returned for analysis.There have been no other complaints reported in the lot number.The root cause for the reported complaint could not be determined.No sample was returned for analysis.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received reporting the increased glare sensitivity can be explained by the very strong glistening of the lens surface.

• 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
• MDR Report Key: 11636243
• Report Number: 9612169-2021-00078
• Device Sequence Number: 17064870
• Product Code: HQL
• UDI-Device Identifier: 00380650130310
• UDI-Public: 00380650130310
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.205
• Device Lot Number: 21021290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 05/18/2021; 06/11/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/14/2021; 05/21/2021; 07/01/2021
• 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: Required Intervention