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

Model Number	ZCT150
Medical Device Problem Code	Unintended Movement (3026)
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).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that patient was scheduled for lens exchange (b)(6) 2019.Lens implant in patient¿s right eye.Intraocular lens master recommended an 18.50, ora (ocular response analyzer) suggested 20.50.Lens model zct150 +20.5 diopter was initially implanted resulting in a +1.25 -.75 x 127 refraction post operatively.Lens position was at 165 degrees.The patient had 2+ posterior chamber opacification (pco).Patient noted to have long eyes.(b)(6) 2019, patient's right eye, ucva (uncorrected visual acuity) 20/50+ and bcva (best corrected visual acuity) 20/20.Additional information was received, and it was learnt that lens was explanted in secondary surgical procedure due to anisometropia.There was no incision enlargement, no sutures, no vitrectomy required.Patient was doing well.No further information provided.
Additional Manufacturer Narrative
Correction: upon review of complaint, it was realized that there was no tecnis toric iol rotation >= 10 degrees, post implantation.No further information was provided.All pertinent information available to johnson and johnson surgical vision has been submitted.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 9/6/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The product was received within the replacement lens' daisy wheel lens casing kept inside of a resealable plastic biohazard specimen bag.A visual inspection of the lens with the unaided eye revealed 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 event is not confirmed.Manufacturing record review: he manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed no additional investigation requests received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 8952770
• Report Number: 3011852734-2019-00173
• Device Sequence Number: 2541398
• Product Code: HQL
• UDI-Device Identifier: 05050474552159
• UDI-Public: (01)05050474552159(17)220717
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 10/07/2019; 10/25/2020
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/25/2019; 10/30/2019; 11/11/2020
• 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