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

Model Number	ZCT150
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	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the iol is not being returned for evaluation therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zct150 16.0 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2019.The zct150 16.0 diopter lens was explanted on (b)(6) 2019 due to complaint of refractive iol error due to previous photorefractive keratectomy (prk).The lens was replaced with an zct150 17.5 diopter lens.It was reported there was no complications, no incision enlargement, no vitrectomy, and the lens is not being returned.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section b-3: date of event: was updated from (b)(6) 2019 to (b)(6) 2019 as blurry vision was observed 2 weeks post-op during exam.Section e-1: initial reporter e-mail updated from unknown ¿ information not provided to (b)(4) section h-6: patient code 2137 was added.After further review of the complaint it was determined the reported event is no longer considered to be reportable as the device did not contribute to the event as it was initially reported refractive iol error due to previous photorefractive keratectomy (prk) and replaced with the same model lens with a different diopter (17.5).Therefore, no further information will be provided under this mdr number (2648035-2020-00036).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 (b)(4) 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: 9572513
• Report Number: 2648035-2020-00036
• Device Sequence Number: 11533166
• Product Code: HQL
• UDI-Device Identifier: 05050474552067
• UDI-Public: (01)05050474552067(17)230207
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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
• Report Date (Section B): 12/30/2020
• 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: 02/07/2023
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U160
• 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: 12/17/2019
• Supplement Date Received by Manufacturer: 10/25/2020; 12/03/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 11/04/2020; 12/30/2020
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005