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

Model Number	SA60AT
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
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.Root cause has not been identified.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 intraocular lens (iol) implant procedure, the lens was completely halved.The lens was probably damaged during application by a bad cartridge molding.The lens had to be explanted and then a new iol applied.Surgery got delayed but the patient was not affected.Additional information was requested.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event of lens damage during folding, before implantation with confirmed no patient contact does not meet criteria for reporting as a serious injury.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information reported by nurse that, the lens was not in the eye.The damage occurred during folding, before implantation, so a new lens was used for implantation.The only impact on the patient was the longer entire procedure because of the preparation of a new lens.

• 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: 13141209
• Report Number: 9612169-2022-00002
• Device Sequence Number: 1505584
• Product Code: HQL
• UDI-Device Identifier: 00380652555807
• UDI-Public: 00380652555807
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 06/24/2026
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.200
• Device Lot Number: 25226690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CARTRIDGE.
• Patient Sex: Unknown