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

Model Number	ZLU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Eye Pain (4467)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is since (b)(6) 2020 as reportedly the issues were noted constantly after surgery.Telephone number: (b)(6).The lens is not returning for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, 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.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient who was implanted with an intraocular lens (iol) in the left eye experienced visual issues such as blurry vision, halos and glare, pain, wavy lines and color issues.The patient was dissatisfied and it was indicated that the reported symptoms effected patient's normal daily activities such as driving and reportedly the patient was debilitated.The lens was explanted in a secondary surgical procedure and a competitor non-johnson and johnson lens was used as a replacement.There were no surgical interventions such as vitrectomy, incision enlargement or sutures required.It was confirmed that the patient is doing well and no injury was reported.It was noted that the lens was discarded.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11248804
• Report Number: 9614546-2021-07044
• Device Sequence Number: 16921927
• Product Code: MFK
• UDI-Device Identifier: 05050474690530
• UDI-Public: (01)05050474690530(17)250312
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

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: 03/12/2025
• Device Model Number: ZLU300
• Device Catalogue Number: ZLU300U195
• 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: 01/04/2021
• Initial Report FDA Received Date: 01/28/2021
• 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