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

Model Number	SA60AT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that during implantation of an intraocular lens (iol) the haptic broke during the implantation in both cases, the surgery prolonged, widened cut and placed corneal sutures, after replacing the injector, lenses were implanted without problems.Additional information was requested.
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).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Iol (intra ocular lens) returned pressed down into well area of iol case base.A significant amount of solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is partially adhered, the other haptic is bent.The optic is torn/split-cut, bent and scratched/marked-rejectable.Additional information: "after replacing the injector, lenses were implanted without problems".We are unable to confirm lens position in the cartridge for the advancement.The root cause may be related to the injector.The complainant indicates that after replacing injector, the reported damage did not occur.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.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: 15688636
• Report Number: 9612169-2022-00559
• Device Sequence Number: 20523916
• Product Code: HQL
• UDI-Device Identifier: 00380652555784
• UDI-Public: 00380652555784
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 03/10/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.190
• Device Lot Number: 25389044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown