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

Model Number	SA60AT
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, when injected the intraocular lens into the eye, the posterior haptic was missing.It was stuck to the injector.Then it was removed and implanted another one.There was no patient harm and patient was not hospitalized as a result of this event.Surgery was completed at the same time.Additional information was requested, but no further information is available.
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.Photo provided showing lens outside of the lens case.The optic appears to be damaged and one haptic is broken/torn and stuck to the optic surface.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Only photo was returned.Based on our observation of the attached photo, the optic appears to be cut in the centre and one haptic is broken/torn and stuck to the optic surface.The observed condition (optic cut in the centre) is consistent with lens having been explanted.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
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: 17037456
• Report Number: 9612169-2023-00415
• Device Sequence Number: 12365439
• Product Code: HQL
• UDI-Device Identifier: 00380652555845
• UDI-Public: 00380652555845
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2023

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: 06/23/2026
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.220
• Device Lot Number: 25184012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/20/2023; 07/20/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/17/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: ENDOCOAT VISCOELASTIC (OTHER BRAND).; MONARCH III IOL CARTRIDGE C.; MONARCH III IOL INJECTOR.
• Patient Age: 37 YR
• Patient Sex: Female