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

Model Number	SA60AT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A physician reported that, during intraocular lens (iol) implant procedure, it was noted that, there were 02 lenses, one on top of the other, and it was necessary to explant one of them.Additional information was received that, there were two iols in the capsular bag.Also there was a patient harm associated with the event.The patient had developed corneal edema.As a result the patient was hospitalized and received steroid-based treatment.The symptom was continuing.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.The product history records confirm that the product met release criteria.There have been no other complaints for this lot.Investigation has been completed based on current information.No further action is warranted at this time.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: 13976542
• Report Number: 9612169-2022-00143
• Device Sequence Number: 14654046
• Product Code: HQL
• UDI-Device Identifier: 00380652555883
• UDI-Public: 00380652555883
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.240
• Device Lot Number: 21290358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female