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

Model Number	ZCT150
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that tecnis toric intraocular lens (model zct150, +26.5 diopter) was explanted in a secondary procedure from patient¿s left eye because of patient immediately experiencing poor distance vision due to myopic outcome of -1.50d.Patient was status post -op hyperopic and had underwent lasik prior to cataract surgery.During the explant procedure and incision enlargement was required and two sutures were used to close the incision.The explanted lens was replaced with a model zct150, +24.5 diopter iol.Patient was reported to be doing good at discharge.No further information provided.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7491867
• Report Number: 9614546-2018-00436
• Device Sequence Number: 11188745
• Product Code: HQL
• UDI-Device Identifier: 05050474552272
• UDI-Public: (01)05050474552272(17)191105
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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: Physician
• Device Expiration Date: 11/05/2019
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/07/2018
• 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: 54 YR