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

Model Number	SN60WF
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non-healthcare professional reported that, lens was hard to fold into cartridge.The lens struggled to advance forward with introducer and got stuck at the end of the cartridge in the patient's eye.
Additional Manufacturer Narrative
The product was returned for analysis.The lens was returned partially inserted into the loading area of a company cartridge.It appears to have been placed there for return.The returned company cartridge was evaluated.Inadequate viscoelastic is observed in the cartridge.The cartridge has evidence it was placed into a handpiece.A large aneurysm was observed, which started in the nozzle on the right side.The aneurysm was torn where it entered the thinner tip material.Heavy stress was observed.The observed damage would indicate the lens was delivered.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was removed during cleaning and placed in a transfer case.The root cause for the reported "lens stuck" may be related to a failure to follow the instruction for use (ifu).There did not appear to be adequate viscoelastic in the returned cartridge.Top coat dye stain testing was conducted with acceptable results.The returned company cartridge nozzle had extensive damage.A large aneurysm was observed that splits as it extends into the thinner tip area.The damage on the right side of the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.Damage in the thick cone wall section has been associated with the use of cold viscoelastic.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL 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: 12099496
• Report Number: 9612169-2021-00143
• Device Sequence Number: 3820773
• Product Code: HQL
• UDI-Device Identifier: 00380655093283
• UDI-Public: 00380655093283
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 06/30/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.245
• Device Lot Number: 21277685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 01/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM; MONARCH III CARTRIDGE D; DUOVISC VISCOELASTIC SYSTEM
• Patient Sex: Unknown