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

Model Number	SN60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Additional observations were as follows: iol was returned pressed down into well area of iol case base.Solution is dried on both surfaces of the optic and both haptics.The optic is scratched/marked - rejectable.We are unable to determine the root cause for the reported complaint " smudge on the lens".The returned iol shows evidence of possible handling by the customer due to the presence of solution.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify that the damage was present when opened and if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.There are no other complaint in the lot.This product malfunction was originally reported under an alternative summary report.The sample has been returned and investigation was updated, which prompts evaluation and conclusion coding to be updated.As the alternative summary report has been revoked, the updated information (product investigation and coding) is being sent via this 3500a report.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the lens was noted to have a smudge.There was no harm to the patient and another lens was implanted instead.

• 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: 11613885
• Report Number: 9612169-2021-00075
• Device Sequence Number: 14234233
• Product Code: HQL
• UDI-Device Identifier: 00380655093115
• UDI-Public: 00380655093115
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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: 09/30/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.160
• Device Lot Number: 21229217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1