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

Model Number	DIU150
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was noted to experience a myopic refractive surprise following the implantation of a single piece preloaded toric intraocular lens (iol) in the right eye starting at pom #1.The visual symptoms were first observed during a post-operative examination.The patient also expressed dissatisfaction with the uncorrected vision following cataract surgery.The manifest refraction (mrx) was a -0.75 sph, whereas the target was -0.25 diopter.The original lens was subsequently explanted during a secondary surgery and was replaced with a johnson and johnson iol of the same model with a 23.0 diopter.The pre-operative bscva was 20/25-2 and the post-operative bscva was 20/20-1.Daily activities were affected specifically difficulty driving and working.No unplanned surgical interventions such as, incision enlargement, sutures, or vitrectomy were required.No medication prescribed that was outside of the standard of care and no reported surgical delays.Directions for use was followed.The patient has fully recovered.No further information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown/not provided section h3: the device was not returned for evaluation; 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 the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, no additional information has been received.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: 25211613
• Report Number: 3012236936-2026-000137
• Device Sequence Number: 10355018
• Product Code: MJP
• UDI-Device Identifier: 05050474746619
• UDI-Public: (01)05050474746619(17)280428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: DIU150U235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White