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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient hasn't seen well since the intraocular lenses (iols) were implanted in both eyes.The patient reported being unable to see at night because the headlights engulf entire cars.The patient still drives at night, but has to be very careful.The patient can still can see during the day, but night time is the worse and can't look directly at outside lights at all.The visual issues are in both eyes and started right after the surgery, but the patient could not provide exact date.The patient reported not really being able to do the things the patient wants to do.The patient would like to remove the iols from the eyes, but was told that it is not possible because it would detach the retina.The iols for both eyes remain implanted.The patient reported having no pre-existing conditions.No additional medical or surgical intervention has been required.There was no complication or any patient injury during the implant surgery.The patient reported that the eyes are dry a lot and the patient uses over the counter lubricating drops.No further information was provided.This report is for the patient's right eye event.A separate report was filed to capture the left eye event.
Additional Manufacturer Narrative
Date of event: unknown, requested but not provided.The best estimate date is between (b)(6) 2017 and (b)(6) 2022.If explanted, give date: not applicable, as 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, 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 & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14116458
• Report Number: 3012236936-2022-00997
• Device Sequence Number: 2291036
• Product Code: MFK
• UDI-Device Identifier: 05050474560772
• UDI-Public: (01)05050474560772(17)191005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

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: 10/05/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0250
• 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: 03/25/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White