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

Model Number	ZCT450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate between (b)(6) and (b)(6) 2018.(b)(4).Device evaluation: product testing could not be performed because the product was not returned.The complaint issue reported was not verified.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.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 a zct450 20.0 diopter intraocular lens (iol) was implanted in the patient¿s operative eye on (b)(6) 2018.The lens was later explanted on (b)(6) 2018 due to residual astigmatism despite the lens being a toric lens, the patient still had as much astigmatism as before the toric lens was implanted.The zct450 was replaced with a pcb00 21.0 diopter iol.The patient is reported to be doing well post exchange.Customer indicated that the complaint product will not be returned for evaluation.No additional 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 AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8154162
• Report Number: 9614546-2018-01162
• Device Sequence Number: 244158
• Product Code: HQL
• UDI-Device Identifier: 05050474602984
• UDI-Public: (01)05050474602984(17)230513
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2023
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 11/05/2020
• 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
• Date Report Sent to FDA: 01/01/2005