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	Vitrectomy (2643)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was not implanted.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient had a vitrectomy performed, and because of this, the initially chosen lens (zct150 22.0 diopter lens) was not used and a different lens was then used.No additional information was provided.
Additional Manufacturer Narrative
Correction: in review, this is a duplicate report of medwatch 9614546-2018-00437.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 9614546-2018-00439.Any additional follow up will be reported under medwatch 9614546-2018-00437.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7493224
• Report Number: 9614546-2018-00439
• Device Sequence Number: 10846226
• Product Code: HQL
• UDI-Device Identifier: 05050474552180
• UDI-Public: (01)05050474552180(17)210508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 05/14/2018

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: Physician
• Device Expiration Date: 05/08/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/13/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/14/2018
• 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