MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number	ZCT150
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the product was returned to the manufacturing site for evaluation.The product was received within its replacement lens casing.A visual inspection of the returned lens shows it was cut in two pieces, most probably to aid in the explant.One piece was received stuck to the adhesive side of a sticker included with the return.The lens piece was removed from the sticker.Traces of paper fibers and ovd (ophthalmic viscosurgical device) were seen on the lens surfaces.The lens was cleaned with purified water and dried with compressed air to ease inspection.Further examination under a microscope shows minor cosmetic damage on the lens surface.How and when the damage was introduced is unknown; however, the lens condition is consistent with one that has been cut and removed from the eye.The reported complaint event could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zct150, 15.5 diopter lens was explanted from the patient¿s right eye due to an issue with the lens.The lens was replaced with the same model but a smaller 12.0 diopter lens.Through follow-up, the customer explained that the wrong lens power was used.They could not confirm if there was something wrong with the iol.There were no complications of any kind such as incision enlargement, vitrectomy, capsule tear or sutures reported.No further information was provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9269801
• Report Number: 2020664-2019-00008
• Device Sequence Number: 13934957
• Product Code: HQL
• UDI-Device Identifier: 05050474552050
• UDI-Public: (01)05050474552050(17)211004
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/02/2019
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005