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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempt has been made to obtain missing information; however, to date a response has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient had the intraocular lens (iol) implanted in their left eye.Ora (occular response analyzer) was used after lens was implanted.Due to the refractive outcome, the lens was explanted and another lens, a model zcb00 was implanted instead.There were no complications.No further information was available or provided.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 10/23/2019.Device returned to manufacturer?: yes.Device evaluation: the intraocular lens was received october 23, 2019 for investigation.The product was received in a lens case.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens, additional analysis is not possible.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the intraocu lar lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.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.
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: 9036736
• Report Number: 9614546-2019-00857
• Device Sequence Number: 16689649
• Product Code: HQL
• UDI-Device Identifier: 05050474552579
• UDI-Public: (01)05050474552579(17)201214
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 12/14/2020
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 10/25/2020
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/31/2019; 11/10/2020
• 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