MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Halo (2227)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was implanted in patient's right eye.During a follow-up check-up on the same day, the patient experienced elevated pressure in his vision and was administered eye drops, followed by a 45-minute waiting period.Upon re-examination, the pressure remained high, and the patient was advised to consult the surgeon.The patient stated that his vision had not improved, remained foggy, and that he observed rainbow colors when looking at lights.The following day, the patient reported a slight improvement in his vision, though it remained foggy with persistent rainbow effects when looking at the lights.The patient confirmed the surgeon had provided eye drops and discharged him to recover at home.No further information received.
Additional Manufacturer Narrative
Section a2, a4, a5, a6: information unknown/not provided.Section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section h3: the device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - impact code: 4613 blurry vision, 4613 halo vision.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• 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: 24918251
• Report Number: 3012236936-2026-000100
• Device Sequence Number: 16034981
• Product Code: HQL
• UDI-Device Identifier: 05050474636149
• UDI-Public: (01)05050474636149(17)290103
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: DCB00
• Device Catalogue Number: DCB0000230
• 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: 01/03/2026
• 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 Sex: Male