MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it was discarded by the customer; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, and complaint trending 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis toric intraocular lens (iol) was explanted from the patient's eye during secondary procedure.Complaint description, anisometropia, debilitating.Originally, the surgeon targeted near intermediate vision correction.Patient was not satisfied with the refractive outcome with measured of residual astigmatism.After many visits, and was referred to a corneal specialist, a lens exchange was required.The replacement lens is a standard monofocal lens and patient is happy with the surgery outcome.Pre-operative visual acuity (va) was 20/70 near, and post-operative va is 20/40 near.At explant the incision was enlarged to remove the lens and sutures were required.The explanted lens was discarded.No additional information provided.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; gronigen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11143480
• Report Number: 9614546-2021-07011
• Device Sequence Number: 837636
• Product Code: HQL
• UDI-Device Identifier: 05050474657892
• UDI-Public: (01)05050474657892(17)240829
• Combination Product (Y/N): N
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: Health Professional
• Device Expiration Date: 08/29/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/08/2021
• 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: 69 YR