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

Model Number	SA60WF
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not 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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, lens did not advance well during implantation, lens was stuck in the injector.There was no patient harm.Additional information was requested and received.
Additional Manufacturer Narrative
Only iol was returned for analysis.No cartridge was returned.Additional observations were as follows: iol returned pressed down into well area of iol case base.Solution is dried on both surfaces of the optic and haptics.One haptic is adhered to the optic surface in a folded position, the other haptic is deformed.The optic is intact.The iol met specifications when dimensionally measured for edge thickness and plan view.No cartridge was returned.The file states: ¿per our surgical tech it was more of the cartridge and possibly a staff error".No more information/clarification could be obtained from hcp (healthcare professional).The product investigation could not identify the root cause for the reported complaint "lens did not advance during implantation stuck in the injector" as only the iol was returned for evaluation.No cartridge was returned.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.Based on the results from the product history record, the products met release criteria.There have been no other complaints for this lot.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 12635951
• Report Number: 9612169-2021-00224
• Device Sequence Number: 4343848
• Product Code: HQL
• UDI-Device Identifier: 00380652332538
• UDI-Public: 00380652332538
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 06/30/2022
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.135
• Device Lot Number: 21196339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2017
• 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: DUOVISC VISCOELASTIC SYSTEM.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Sex: Unknown