MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU150
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 Disturbances (2140); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d-6b date explanted: not applicable as the iol remains implanted, therefore not explanted.Section h-3: the device was not returned for evaluation as it remains implanted in the patient¿s ocular dexter (right eye).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 report will be filed.Section h6: health effect - clinical code: 4581 - is to capture eye anatomy issue: pre-existing disease attempts were made to contact the customer account requesting additional information regarding complaint 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 the diu150 22.0 diopter model intraocular lens (iol) was implanted into the patient¿s ocular dexter (right eye).Patient had the iols put in because of cataract surgery and an astigmatism.She reports complaints of blurriness that makes her sick to her stomach because she cannot see distance.Patient informed her doctor who said to give it time and she thinks it needs to be rotated.Patient stated initially she was seeing blue but that has stopped.She could drive after od was done, but after the left eye was done her vision has not evened out enough to allow her to see the distance of street signs etc.The surgeon stated in follow-up that there was no swelling, but had a little divot in her eye but did not think this should impact vision.Due to patient's poor vision, she called another doctor and scheduled an office visit.She was able to read the alphabet sign during the exam and was told she had 20/25 vision.Patient was told there was swelling, but that everything looks good.Patient uses refresh with the antibiotic drops prescribed by the doctor.She also has dry eye, and used to use xiidra (twice a day), but currently is not.No further information is available.This report captures the iol in the patient's ocular dexter (right eye).A separate report will be filed for the patient's ocular sinister (left eye).

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19449439
• Report Number: 3012236936-2024-000154
• Device Sequence Number: 15640188
• Product Code: MJP
• UDI-Device Identifier: 05050474746589
• UDI-Public: (01)05050474746589(17)260305
• 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: 2024
• 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): 06/03/2024

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: 03/05/2026
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U220
• 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: 05/06/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2023
• 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: Required Intervention
• Patient Sex: Female