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

Model Number	ZCT525
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, but the best estimate is between (b)(6) 2018 and (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that the tecnis toric intraocular lens (model zct525 +22.5 diopter) was explanted from the patient¿s operative eye in a secondary surgical procedure due to an incorrect refraction.Reportedly, another lens with the same model but different diopter size, was implanted as a replacement.The patient was reported doing fine.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in review of the file, it was identified that the serial number reported in this event, was already captured and reported in medwatch, manufacturing report number 9614546-2018-00758.Hence, no further information will be provided in this filing and all pertinent information was captured and reported under manufacturing report number: 9614546-2018-00758.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.; santa ana CA
• MDR Report Key: 7821947
• Report Number: 3011852734-2018-00152
• Device Sequence Number: 1313498
• Product Code: HQL
• UDI-Device Identifier: 05050474603622
• UDI-Public: (01)05050474603622(17)220801
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 11/02/2020
• 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: 08/01/2022
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U225
• 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: 07/31/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 10/25/2020
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/02/2020
• 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