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	Flashers (1864); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced worsening vision in both eyes following implantation of preloaded monofocal toric intraocular lenses (iols).The patient reported significant light sensitivity, particularly at night while driving, with headlights causing severe irritation, as well as persistent double vision and poor distance vision in the right eye.The patient stated that these symptoms began immediately after the surgical procedures, although the exact surgery dates were not provided.The patient also reported experiencing starburst effects prior to surgery; however, following cataract surgery, the starbursts became significantly brighter and more pronounced, increasing subjectively from approximately five to fifty starbursts, described as clearer and more vibrant.The patient was prescribed eye drops, including prednisolone acetate, beginning on march 18, 2026, which reportedly improved pain and light sensitivity.During a follow up vision evaluation on (b)(6), 2026, the patient continued to report poor vision and double vision in the right eye, while the left eye was reported to have good vision.The physician initially suggested that the intraocular lens in the right eye may have shifted; however, during subsequent evaluations, the physician reportedly confirmed that the lenses were stable, with no rotation or movement observed.The patient reported that double vision persisted only in the right eye and that overall visual sharpness in the right eye remained inferior compared to the left.The patient continued to experience nighttime starbursts, which the patient attributed to astigmatism, although the physician reportedly confirmed that astigmatism had been corrected.The patient reported gradual adjustment to the visual changes and stated that the lenses were functioning well, resulting in noticeable improvement overall.The patient recently visited the physician and plans to return for fitting of bifocal glasses, with correction focused on distance vision for the right eye and some near vision for the left eye.Treatment with prednisolone acetate was initially prescribed for two weeks and was subsequently extended for additional periods, totaling up to six weeks, per physician recommendation.No additional medical or surgical interventions were required.The patient confirmed that there were no capsule tears, incision enlargements, or sutures required during the surgeries.At the time of reporting, the patient was awaiting further post-operative evaluation with the surgeon.No further information was provided.The patient underwent bilateral intraocular lens implantation.This report pertains to the left eye.A separate report will be submitted for the right eye.
Additional Manufacturer Narrative
Section d6b: if explanted; give date: not applicable as the device remains implanted.Section h3: the device was not returned for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of this 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, 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: 24918622
• Report Number: 3012236936-2026-000096
• Device Sequence Number: 10420489
• Product Code: MJP
• UDI-Device Identifier: 05050474746404
• UDI-Public: (01)05050474746404(17)290108
• 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: 2026
• 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): 04/18/2026

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 Model Number: DIU150
• Device Catalogue Number: DIU150U130
• 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: 03/25/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White