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

Model Number	ZCT525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: unknown/not provided.(b)(4).Attempts have been made to obtain missing information; however, no definitive 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 model zct525 21.0 diopter intraocular lens (iol) was explanted due to the patient experiencing blurry vision.The explanted lens was replaced with a model zct225, 21.5 diopter iol.At explant there was no incision enlargement, sutures or vitrectomy required.It was noted the patient was doing well post-exchange.No other information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation? yes.Returned to manufacturer on: 10/14/2019.Device returned to manufacturer? yes.Device evaluation: the returned sample was received on 14-oct-19.A visual inspection of the lens shows it 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.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: 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: 9170219
• Report Number: 3011852734-2019-00188
• Device Sequence Number: 2538215
• Product Code: HQL
• UDI-Device Identifier: 05050474603592
• UDI-Public: (01)05050474603592(17)220628
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 06/28/2022
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• 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: 10/22/2019; 10/25/2020
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 11/15/2019; 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: 71 YR
• Date Report Sent to FDA: 01/01/2005