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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient is experiencing double vision and ghosting with an intraocular lens (iol) in both eyes (ou).Patient was using over-the-counter (otc) eye drops and prescription drops as well (steroid & antibiotic drops).Patient had a second procedure done on (b)(6) 2022 that the patient referred to as a ¿jag laser¿ procedure to remove membranes from his eyes, however, he is still experiencing seeing double-images.Through follow-up, it was learned that the steroid and antibiotics eye drops were prescribed right after the surgery as a standard of care.The patient is only taking over-the-counter (otc) eye drops to help with the dry eyes.The patient reported the dry eyes started after he got the iol implants.The patient also complained of not being able to see clearly at all ranges in both eyes.Patient indicated that it is hard to focus close-up which affects his work, because he is a craftsman and his work has gone down as a result.He also is seeing halos and glare around lights, sees 10-15 rings around lights since the iol implants in both eyes.The double vision ou gets worse with distance vision.The patient stated that the yttrium aluminum garnet (yag) laser was performed to correct the visual problems, but has not helped.The patient is getting fitted for contact lenses for the right eye first to get 20/20 vision and hopefully remove the double vision.At this time both lenses remain implanted.No other information was provided.Patient had bilateral lens implants.This report captures the lens implanted in patient's left eye.A separate report will be filed for the right eye.
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date is between 10/26/2021-4/6/2022.If explanted; give date: n/a (not applicable).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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 14226288
• Report Number: 3012236936-2022-01128
• Device Sequence Number: 20144469
• Product Code: HQL
• UDI-Device Identifier: 05050474750654
• UDI-Public: (01)05050474750654(17)240325
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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: 03/25/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU190
• 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: 04/06/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White