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

Model Number	ZCT450
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Dry Eye(s) (1814); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.Lens remains implanted.The device has not been returned for evaluation as it remains implanted; 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zct450 18.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Post-op day one, patient's visual acuity was reported as 20/25+ and she was happy.By 1-week post-op, visual acuity was 20/40 and refracts to -1.0, +2.50.Physician also noticed, after dilating the patient, the lens appeared to have moved from the original access of 109 degrees to 135 degrees.Through follow up, realignment surgery was performed (b)(6) 2018.On post visit, (b)(6) 2018, results were pl +0.50 20/25- and patient was extremely happy with results.Further information stated patient had punctate epithelial erosion (pee).This was observed on all three post-op visits and patient had a pre-existing dry eye condition.The dry eye resolved between week 2 and 3 after discontinuing post-op drops and use of non-prescription artificial tears (npat) every hour/two and pm.Patient may have had possible sensitivities to topical betadine and pre-op dilation.Patient returned to baseline artificial tears (at) maintenance program and surface baseline by week 3 in both prior surgeries and expect the same here.Exact same surface findings after first eye (left).Right eye post op had exact same surface findings after both surgeries.No additional information was provided to johnson & johnson surgical vision.
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; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8144729
• Report Number: 9614546-2018-01156
• Device Sequence Number: 2070366
• Product Code: HQL
• UDI-Device Identifier: 05050474602953
• UDI-Public: (01)05050474602953(17)230130
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Report Date (Section B): 11/05/2020
• 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: 01/30/2023
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U185
• 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: 11/10/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 11/05/2020
• 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: 64 YR
• Date Report Sent to FDA: 01/01/2005