MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. TECNIS IOL; Lens, Intraocular, Toric Optics

Model Number	DIU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a monofocal toric intraocular lens (iol) was explanted from a patient's left eye since the patient experienced a significant change in corneal astigmatism from preoperative status, resulting in diplopia.The patient's best spectacle-corrected visual acuity improved from 20/60 preoperatively to 20/20 postoperatively.The issue did not affect patient's daily activities.No vitrectomy or incision enlargement required, the patient did not seek medical attention and no medication outside of standard of care was prescribed.The replacement lens implanted was the same model and diopter but different cylinder (diu150, 19.5d).The patient is temporarily impaired.Direction for use were followed.The lens involved is not available for return.No additional information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown, information was asked but not provided.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.However, complaint issues reported are not related.Therefore, no further actions are required.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.

• 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: 50025575
• Report Number: 3012236936-2026-000222
• Device Sequence Number: 16087191
• Product Code: MJP
• UDI-Device Identifier: 05050474747715
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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: DIU300
• Device Catalogue Number: DIU300U195
• 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): Yes
• Date Device Manufactured: 02/17/2025
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Race: Black Or African American