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

Model Number	SA60AT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned to the manufacturing site.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.No other complaints for the lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during intraocular lens (iol) implantation procedure, lens didn't come out of the injector properly, got caught in the wound and only partially entered the eye.Due to scant mascara in the surgical field the first attempt failed.Surgeon opted to use the backup for safety purposes.Mascara was tough to remove fully, it looked like a small amount of residual likely left over from one to several days prior.It was reported that the primary issue was a faulty injection.
Additional Manufacturer Narrative
The product was returned for analysis.Additional observations were as follows: iol returned positioned incorrectly in the iol case.A significant amount of solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic has particulate -rejectable.The iol met specifications when dimensionally measured for edge thickness and plan view.No cartridge was returned.Additional information: the complainant indicates the use of provisc as a viscoelastic, which is not qualified for use with associated iol model/ cartridge/handpiece combination.The product investigation could not identify the root cause for the reported complaint "lens did not come out of injector properly, got caught in the wound and only partially entered the eye".Only iol was returned for evaluation.No cartridge was returned.The reported complaint is lacking in additional details in regard to the reported event "lens did not come out of injector properly".Due to this, we are unable to complete a thorough investigation to determine a root cause.The dimensions of the lens were tested using an approved template and results show the lens dimensions to be within specification.The reporter states the use of a non-qualified combination.The use of nonqualified combination may result in delivery issues and/or damage.All product and batch history records are quality reviewed prior to product release.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
• MDR Report Key: 12168151
• Report Number: 9612169-2021-00151
• Device Sequence Number: 4198657
• Product Code: HQL
• UDI-Device Identifier: 00380652555784
• UDI-Public: 00380652555784
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 03/31/2025
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.190
• Device Lot Number: 21271396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE