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

Model Number	CNW0T3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	02/02/2022
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, following intraocular lens (iol) implant procedure, a scratch was noted on the iol.The surgery was completed after replacing the iol with another one.Additional information was received by the same reporter that, there was no potential health impact to the patient.The surgery was completed without any problem.Postoperatively, the patient had no problems.Visual acuity is expected to improve as the corneal edema decreases.
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, following intraocular lens (iol) implant procedure, a scratch was noted on the iol.The surgery was completed after replacing the iol with another one.Additional information was received by the same reporter that, there was no potential health impact to the patient.The surgery was completed without any problem.Postoperatively, the patient had no problems.Visual acuity is expected to improve as the corneal edema decreases.
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and documentation 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
Additional information was received and stated that, there was no inflammation and problem after the surgery, and va was increased to 1.2.During the implant, the surgeon did not realize the problem of iol right after inserting iol into the eye, and the surgeon found the crack in the optical part during initial procedure of the alignment of the toric, and he also felt the fixation of the alignment was different from usual.Therefore, iol was exchanged to another one.
Additional Manufacturer Narrative
The product was returned for analysis and the reported damage was observed.Additional observations were as follows: iol returned in (b)(4) pieces adhered to gauze tape in non-company peel pouch.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned, the other haptic is scratched/marked-rejectable.The optic is torn/split-cut dividing in two(2) and scratched/marked-rejectable with adhered fibers.We are unable to determine the root cause for the reported complaint "scratched iol".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.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.There have been no other complaints reported in the lot number.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: 13534745
• Report Number: 9612169-2022-00069
• Device Sequence Number: 4227834
• Product Code: MJP
• UDI-Device Identifier: 00380652409711
• UDI-Public: 00380652409711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• 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,Followup
• Report Date (Section B): 05/16/2022

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: 01/31/2024
• Device Model Number: CNW0T3
• Device Lot Number: 21283821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 02/18/2022; 04/21/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/14/2022; 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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: CLAREON MONARCH IV IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown