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

Model Number	ZCT300
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.Device evaluation: product testing could not be performed because the actual lens was not returned as it was discarded.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no similar complaints were received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that while inserting the lens into the eye, as the lens opened the capsular bag was noted to be torn and the lens was drifting out of position and tilting inferior.The lens was removed and an anterior vitrectomy was performed.There was no mention if this issue was due to the lens.There was no patient injury.Lens from another manufacturer was used as the replacement lens for the patient.The explanted lens was discarded.No further information 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 (b)(4) 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: 9983398
• Report Number: 9614546-2020-00191
• Device Sequence Number: 19807386
• Product Code: HQL
• UDI-Device Identifier: 05050474553361
• UDI-Public: (01)05050474553361(17)200329
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• 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: 03/29/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U220
• 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: 03/27/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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: 64 YR
• Date Report Sent to FDA: 01/01/2005