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

Model Number	ZCT400
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	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report indicating the iol was explanted from the patient's right eye due to hyperopic surprise post surgery.The patient experienced very blurry vision at both distance and near.Their visual acuity pre-op is 20/25 with correction and post-op is 20/70+.The incident date was reported as (b)(6) 2020 and hyperopia was confirmed (b)(6) 2020.When the iol was explanted the incision was enlarged and sutures were required.The iol was replaced with another iol model zct400, but higher diopter 14.0.This lens remains implanted in the patient's eye.No further information was provided.
Additional Manufacturer Narrative
The initial medwatch# 9614546-2020-00277 explained there was incision enlargement in b5.However, incision enlargement was not coded in h6.Section h6: patient code, 3191: incision enlargement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.Placeholder.
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: 10334910
• Report Number: 9614546-2020-00277
• Device Sequence Number: 19623667
• Product Code: HQL
• UDI-Device Identifier: 05050474553729
• UDI-Public: (01)05050474553729(17)200727
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 07/27/2020
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U105
• 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: 07/01/2020
• Supplement Date Received by Manufacturer: 08/17/2020; 09/25/2020; 10/25/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/18/2020; 09/25/2020; 10/29/2020
• 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: 62 YR
• Date Report Sent to FDA: 01/01/2005