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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was removed/replaced in the initial surgery.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that capsule tore at surgeon and patient interface while inserting lens into the eye.The lens was removed and replaced in same surgical procedure.Reportedly anterior chamber lens was placed in patient¿s operative eye.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 9/2/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The lens was inspected by a qualified final inspection operator using 12x magnification.It can be seen that the optic was torn, most probably to make explant possible.No further anomalies were identified.The complaint cannot be confirmed.Manufacturing record review: he 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 & johnson surgical vision, inc.Has been submitted.
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: 8951861
• Report Number: 9614546-2019-00794
• Device Sequence Number: 2768859
• Product Code: HQL
• UDI-Device Identifier: 05050474552173
• UDI-Public: (01)05050474552173(17)200914
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 09/14/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/18/2019; 10/25/2020
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/25/2019; 11/11/2020
• 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