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 Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
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 health professional reported that during an intraocular lens (iol) implant surgery, the lens did not unfold properly.Additional information has received reporting that there was contact with the patient but there was no patient harm.
Additional Manufacturer Narrative
No iol returned for evaluation.P&l components along with lens case were returned in the carton.Based on these investigation findings and the lack of sample, we are unable to determine the root cause for the reported complaint.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received confirming that there was a lens folding issue in the delivery system and the lens was not implanted.
Additional Manufacturer Narrative
As per follow up information product problem code was updated to 1254 from 1255.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
• MDR Report Key: 12074648
• Report Number: 9612169-2021-00142
• Device Sequence Number: 4304372
• Product Code: HQL
• UDI-Device Identifier: 00380655095652
• UDI-Public: 00380655095652
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2021

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: 12/31/2022
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.120
• Device Lot Number: 21210094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 08/23/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/25/2021; 09/03/2021
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE