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

Model Number	ZCT450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but best estimate would be between (b)(6) 2019 and (b)(6) 2019.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The surgeon reported that he has a patient who was a -10 and needed cataract surgery and also had 4 diopters of cylinder (astigmatism).The doctor implanted a zct450 19.0 diopter intraocular lens (iol) on (b)(6) 2019.Patient ended up with a refraction of -10.0 x 4.75 at 85 degrees.The patient is still very minus and has significant residual cylinder.The lens was explanted on (b)(6) 2019.The patient has recovered and no complications were reported post-operatively.No further information has been provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 10/22/2019.Device returned to manufacturer: yes.Device evaluation: the lens was received within a plastic sample jar labelled with patient and product information that could positively identify the product.A visual inspection of the product shows the lens was cut in half, most probably to aid in explant.Based on the condition of the return, further analysis is not possible.The reported complaint issue could not be confirmed.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: after submission of the initial report, it was realized that date received by manufacturer was inadvertently populated as 9/16/2019.The correct date received by manufacturer is 9/13/2019.Additional info: the explanted lens is not suspected of having anything wrong with it.Simply, what happened was an error is selecting the power of first implant.Device evaluation: the product was not returned to the manufacturing site; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson and 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: 9183164
• Report Number: 3011852734-2019-00190
• Device Sequence Number: 16837830
• Product Code: HQL
• UDI-Device Identifier: 05050474602960
• UDI-Public: (01)05050474602960(17)230704
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 07/04/2023
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 11/18/2019; 10/25/2020
• Initial Report FDA Received Date: 10/12/2019
• Supplement Report FDA Received Date: 11/04/2019; 11/20/2019; 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
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005