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	Visual Impairment (2138); Prolapse (2475)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded monofocal toric intraocular lens (iol) was implanted in the patient's right eye.Following the procedure, the patient experienced an unexpected postoperative refractive outcome (myopic surprise), and the physician planned to exchange the implanted lens for another iol of the same model with a different cylinder and power (diu225, +22.5 d).The preoperative refraction was reported as -0.50 -0.75 × 105, and the postoperative refraction was reported as plano sphere.Additional information subsequently confirmed that an explant procedure was performed.During the lens exchange procedure, significant anterior segment manipulation was required to explant the original lens.An unplanned second incision was created, and the initial incision was sutured.Intraoperative iris prolapse (mechanical complication) occurred and was successfully managed.The replacement iol was implanted through the second incision without reported issues.Miochol was administered intraoperatively.No capsule tear or other patient injury was reported, and no additional surgical interventions were required.At the time of reporting, the patient was doing well, was satisfied with the outcome, and no ongoing issues were reported.No further information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between feb 18, 2026 and may 13, 2026.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 this review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain additional information regarding the event; however, the information was not provided.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 ; +1(714)247-8552
• MDR Report Key: 50015302
• Report Number: 3012236936-2026-000210
• Device Sequence Number: 9606416
• Product Code: MJP
• UDI-Device Identifier: 05050474746619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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?: No
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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: 61 YR
• Patient Sex: Female
• Patient Race: White