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

Model Number	SN60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis, lens remains implanted in eye.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 physician reported that, during intraocular lens (iol) implant procedure, debris found on iol after implanting.The debris was removed by a cystotome and the iol is clear again.There was a patient contact, however no patient harm was involved.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned for analysis, lens remain implanted.Only video was returned.The video was provided showing iol implantation using company cartridge and injector.The lens preparation for implantation is not provided.The lens position for implantation appears to be acceptable.Once the iol is implanted, a large mark/ particulate is visible over the iol optic.The particulate is on the exterior surface of the iol.The surgeon successfully removes the particulate using additional instrumentation.Based on our observations of the returned video, a large particulate is observed on the exterior surface of the iol.A definitive determination of the origin of the observed "debris" cannot be made without the evaluation of the physical sample.A final root cause cannot be determined based on available information.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: 14652522
• Report Number: 9612169-2022-00261
• Device Sequence Number: 4867697
• Product Code: HQL
• UDI-Device Identifier: 00380655093313
• UDI-Public: 00380655093313
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: 10/31/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.260
• Device Lot Number: 21288591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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: MONARCH III D CARTRIDGES; PROVISC; UNSPECIFIED CYSTOTOME
• Patient Sex: Unknown