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

Model Number	ZCT525
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as to date the lens remains implanted and therefore not explanted.It was indicated that the lens is not returning for evaluation as to date 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the toric intraocular lens (model zct525 +10.5 diopter) was implanted in the patient's right eye on (b)(6) 2018.There were no patient complication and/or related injury.The intraocular lens (iol) originally placed at 16 degrees, was measured at 37 degrees one day post-op on (b)(6) 2018.Reportedly, there are no plans for iol repositioning.The lens remains implanted in the eye.The outcome does not significantly interferes with the patient's daily activities.No further information was provided.
Additional Manufacturer Narrative
Corrected data: the following additional information was inadvertently not included in the initial mdr report; therefore, it is captured in this supplemental report.Additional information: additional information indicated that the doctor was unhappy with the results on the operative eye and the lens was explanted on (b)(6) 2018.The incision was enlarged from 2.5mm to 3mm and one (1) suture was placed during the lens explantation.There was no vitrectomy required.A replacement lens, model zct450 +10.0 diopter was used.The explanted lens was discarded at the site.The suture was removed two (2) weeks after the surgery.It was reported that the subject has recovered from this iol exchange surgery, is doing well and completed the 6-month study visit on (b)(6) 2018.The subject is due for a 1-year study visit early next year.The following fields were updated accordingly.Both adverse event and product problem.Outcomes attributed to adverse event: required intervention.If explanted, give date: (b)(6) 2018.Type of reportable event: serious injury.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 1/17/2019.Device returned to manufacturer ¿ yes.Device evaluation: the product was received and visual inspection showed that the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: patient code, 3191: unexpected post-op refraction.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7497493
• Report Number: 9614546-2018-00447
• Device Sequence Number: 19274587
• Product Code: HQL
• UDI-Device Identifier: 05050474603387
• UDI-Public: (01)05050474603387(17)201223
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/24/2019
• 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: Physician
• Device Expiration Date: 12/23/2020
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/24/2018; 11/27/2018; 01/30/2019
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 10/28/2018; 12/26/2018; 02/25/2019
• 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: 65 YR
• Date Report Sent to FDA: 01/01/2005