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

Model Number	SN60AT
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A risk manager reported that during a cataract extraction with an intraocular lens (iol) implant procedure, lens became stuck in the incision.Haptic broken off of the lens upon retrieving the lens.There was no serious harm reported.Unexpected or prolonged care was not required.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
The product was returned for analysis.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.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 broken haptic was observed.Intraocular lens returned positioned incorrectly in the intraocular lens case.A significant amount of solution is dried on the intraocular lens.Both haptics are adhered to the optic surface in a folded position, one haptic is broken torn and partially adhered, the other haptic is bent.The optic is intact.We are unable to determine the root cause for the reported complaint "haptic broke off ".The cartridge was not returned.Associated products were not provided.Lens position in the cartridge for the advancement cannot be confirmed.The broken haptic was reported to occur when the lens was removed from the incision after unsuccessful implantation.We are unable to verify if the intraocular lens 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: 16493730
• Report Number: 9612169-2023-00183
• Device Sequence Number: 6366754
• Product Code: HQL
• UDI-Device Identifier: 00380650130532
• UDI-Public: 00380650130532
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 06/30/2025
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.330
• Device Lot Number: 21277211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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
• Patient Sex: Unknown