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

Model Number	ZCT525
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact date of event is unknown.Best estimate provided is about 5-7 days after lens implantation ((b)(6) 2018).The intraocular lens (iol) is not returning for evaluation as it was discarded by the account; 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 and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The surgery center reported of an unexpected post-op outcome due to a possible rotation of a toric intraocular lens (iol), model zct525 (11.5 diopter).It was indicated that the initial position of the iol targeted at 87 degrees upon implantation the patient presented as 20/30 after cataract surgery on day one.The patient then proceeded to say it was almost as if she noticed the lens rotated itself, now her vision in that eye, left eye (os) is 20/80 just under 1-month postop.It was indicated that the doctor wants to rotate the lens around 13-20 degrees to give the patient optimal vision.Pre-operative refraction: -1300 +200 x 085.Post-op refraction -100 +150 x 150.Best corrected visual acuity (bcva): 20/30.On (b)(6) 2018 visit, the current orientation of iol: was reported to be 82 degrees.It was indicated that the initial position of the lens was targeted at 87 degrees upon implantation; however, the account was not sure if that was the position at which the iol was actually placed.The current position of the lens was reported to be 87 degrees.The account consulted with the j&j surgical medical affairs and after reviewing the patient data, medical affaire determined it appears that incorrect toric model was implanted, resulting in an overcorrection of the astigmatism, yielding the residual astigmatism.The doctor decided to perform an exchange for zct400 model lens and reportedly, the iol was explanted on (b)(6) 2018.The lens was discarded by the account.The patient is doing well post explant and no patient injury was reported.
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: 7855160
• Report Number: 9614546-2018-00864
• Device Sequence Number: 1445146
• Product Code: HQL
• UDI-Device Identifier: 05050474603400
• UDI-Public: (01)05050474603400(17)201012
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 11/03/2020
• 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: 10/12/2020
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U115
• 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: 08/14/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 11/03/2020
• 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