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 Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded toric monofocal intraocular lens (iol) was explanted for an initially unknown reason.The lens was discarded and is not available for return.The replacement iol was a non¿johnson & johnson lens.Follow-up information indicated that the toric iol implanted in the right eye was explanted due to capsular bag compromise, which resulted in inadequate capsular support, lens decentration, and instability.The toric iol was removed and replaced with a three-piece iol placed in the sulcus.An anterior vitrectomy was performed due to the compromised capsular bag.No sutures or medications outside the standard postoperative regimen were required.The patient was able to perform daily activities prior to surgery but experienced a loss of two or more lines of best spectacle-corrected visual acuity (bscva).Preoperative refraction was -2.75 +1.25 × 095 with bscva of 20/40.Postoperative refraction was -0.50 +0.75 × 090 with bscva of 20/25.The intended refractive target was plano (0.00 d).The patient was neither overcorrected nor undercorrected, and the residual refractive error was within the typical postoperative range.No significant pre-existing conditions affecting iol power calculation were reported.The postoperative course was stable.The sulcus-implanted iol remained well centered, and the patient demonstrated satisfactory visual recovery.The postoperative refraction after lens exchange was -0.50 +0.75 × 090.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturing site as the device was discarded; therefore, product testing could not be performed, and the reported complaint issue could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.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: 24564881
• Report Number: 3012236936-2026-000064
• Device Sequence Number: 13160218
• Product Code: MJP
• UDI-Device Identifier: 05050474746596
• UDI-Public: (01)05050474746596(17)270109
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/10/2026

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: DIU150U225
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 55 KG