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	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: investigation including root cause analysis is in progress.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported an intraocular lens (iol) was implanted and a mark was noticed on the optical plate.The lens was removed and replaced during the initial procedure with no reported patient impact.Additional information was requested.
Additional Manufacturer Narrative
Evaluation summary: the product was returned for analysis and the reported complaint could not be observed.Additional observations were as follows: only one haptic was returned in the iol case.No remaining iol returned.Solution is observed on the haptic.The product investigation could not identify the root cause for the reported complaint "mark on the optical plate after implantation" as only one haptic was returned for evaluation.The remaining iol was not returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.The product was subject to handling and the reported damage was highlighted post implantation.The returned haptic shows evidence of handling by the customer due to the presence of solution.All product and batch history records are quality reviewed prior to product release.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: 11569004
• Report Number: 9612169-2021-00072
• Device Sequence Number: 4455425
• Product Code: HQL
• UDI-Device Identifier: 00380655093283
• UDI-Public: 00380655093283
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 11/30/2024
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.245
• Device Lot Number: 21261751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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 CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM
• Patient Age: 74 YR