MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T3
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.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 implantation of an intraocular lens (iol) the scratch was found on the lens after implantation.When implanting the iol with the same injector, the scratch was found again.The iol was implanted without problems after replacing the injector with another one.Incision size: 2.4 mm and removal size: 3.5 mm.Additional information was requested and received stating scratch was found on the lens, so the wound was enlarged, the lens was removed, and a second lens was inserted.The second lens had a scratch, but it was left in place because no health hazard was anticipated.There was no potential health impact.Additional information was received stating surgeon requested to investigate the iol.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Iol(intraocular lens) returned pressed down into well area of iol case base.Solution is dried on both surfaces of the optic and haptics, blue marker is also present on one haptic and the optic.Both haptics are bent/deformed.Iol cleaned.The optic is cracked/fractured and scratched/marked-rejectable we are unable to determine the root cause for the reported complaint " scratch found on iol after implantation".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and haptics and blue marker.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 if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15162696
• Report Number: 9612169-2022-00378
• Device Sequence Number: 5881016
• Product Code: MJP
• UDI-Device Identifier: 00380652402309
• UDI-Public: 00380652402309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2024
• Device Model Number: CNW0T3
• Device Lot Number: 25206196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• 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: CLAREON MONARCH IV IOL INJECTOR; UNSPECIFIED IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male