MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
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 nurse reported that during an intraocular lens (iol) implant procedure, it was found a string on the three lenses.The facility has collected the one string in a jar.Additional information has been received and stated that, the damaged optic was found during placement of lens and later it turns out to be a string which could not be removed from the optics during initial procedure.The string was scraped off the optic with a sweep.The device came to contact with the patient.The surgery delayed by more than 1 hour, however, the procedure was completed with the back up lens.There was no negative consequences occurred to the patient.Additional information received and stated that, the lens was explanted during initial procedure and the wound was enlarged during the initial procedure.Additional information was received and stated that, the patient had suture.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.10.The product was returned for analysis and the reported complaint was not observed.No string observed on the lens.Iol (intraocular lens) returned adhered to adhesive tape on a piece of card along with closed lens case.Solution is dried on both surfaces of the optic and haptics.One haptic arm nicked/chipped-rejectable, the other is intact.The optic is torn/split-cut dividing the iol in two(2), is cracked/fractured and scratched/marked-rejectable.Iol cleaned.No fiber/string observed.No root cause identified as the reported complaint "damaged optic turns to string on lens" was not observed.The lens optic was damaged.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 the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in d.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 14185718
• Report Number: 9612169-2022-00180
• Device Sequence Number: 5012207
• Product Code: HQL
• UDI-Device Identifier: 00380652332583
• UDI-Public: 00380652332583
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.160
• Device Lot Number: 21276755
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 12/21/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 07/15/2022; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown