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 Codes	Retinal Degeneration (2049); No Code Available (3191)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 unexpected post-op refraction after implanting model zct150 tecnis toric iols (intraocular lens) 21.0 diopter (d) in her left eye (os).Historically, patient had myopic lasik many years ago.It showed a hyperopic pattern on her topography, as reported by the customer.It was also learnt that she had hyperopic treatment for enhancement.Preoperatively, patient had 1.75 diopters wtr (with-the-rule) astigmatism.Model zct150 was implanted targeting 98 degrees rotation.Post-operatively at 1.5 weeks, iol axis was determined to be at 102 degrees.However, refraction showed +0.50 -2.00 x 080, so + cyl (cylinder) was determined to be at 170 degrees.The account commented that based on (b)(6) software, by rotating the lens 68 degrees counter clockwise, would resolved the cylinder.Repeat topography postoperatively showed 1.34 diopter of wtr astigmatism.Additional information was received and it was learnt that the doctor is planning to rotate the lens.If after repositioning of the lens, there will still be significant residual astigmatism, then the surgeon will exchange the iol for a monofocal lens.No additional information was provided.
Additional Manufacturer Narrative
Additional information received indicated that iol was rotated to 151 degrees on (b)(6) 2018 and it is in targeted position.On the first day, visual acuity was 20/25 (uncorrected), then dropped to 20/40 (uncorrected) on 4 days.Refraction at day 4 was +0.25 - 1.00 x 100.Her last post-op visit was on (b)(6) 2018.Patient's bcva (best corrected visual acuity) was 20/30 and was in targeted position.Patient has also macular degeneration.Planned treatment is still pending.Patient may undergo prk (photorefractive keratectomy) if she's not happy with her vision.The following field was updated accordingly: patient code: additional patient code (2049 - retinal degeneration) added.Patient code: additional patient code (3191 - ¿ lens repositioning/rotation) added.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: 7942484
• Report Number: 9614546-2018-00949
• Device Sequence Number: 857254
• Product Code: HQL
• UDI-Device Identifier: 05050474552166
• UDI-Public: (01)05050474552166(17)220323
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 11/03/2020
• 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: 03/23/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U210
• 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: 09/10/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 10/25/2020
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/28/2018; 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: 68 YR
• Date Report Sent to FDA: 01/01/2005