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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If explanted; give date: n/a (not applicable).To date, the lens remains implanted.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch 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 that patient had 5 diopter hyperopic miss after the implantation of model zct150 +17.50 diopter toric iol (intraocular lens) in her left eye (os).The iol master predicted a plano result with this lens and the lens appears fine at post-op as it is not sitting posterior.Through follow-up, there were no other visual issues reported other than the patient being a +4.00 post-op and patient being unhappy with her visual acuity.It was also indicated that the patient has pseudoexfoliation (pxs) syndrome in her right eye (od).The doctor has not yet made the decision whether it would be best to explant the lens or to do a piggyback iol in the setting of pxs.No additional information provided.
Additional Manufacturer Narrative
Additional information: through follow up with the doctor, it was learned that there is no change in the patient's visual acuity and she remains at +4.0.The doctor decided to give the patient contact lenses and for the time being, there are no plans to explant the lens.The doctor will notify johnson & johnson if there are any more changes or if they decide to explant the lens.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.; santa ana CA 92705
• MDR Report Key: 8259707
• Report Number: 3011852734-2019-00019
• Device Sequence Number: 16664420
• Product Code: HQL
• UDI-Device Identifier: 05050474552098
• UDI-Public: (01)05050474552098(17)210829
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 08/29/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U175
• 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: 12/27/2018
• Supplement Date Received by Manufacturer: 01/25/2019; 10/25/2020
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 01/26/2019; 11/06/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005