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 Code	Blurred Vision (2137)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was explanted from a patient's right eye due to blurry vision.There was no reported patient or user harm associated with this incident.It was indicated that the explanted lens was discarded and is not available for return or investigation.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4, a5 and a6: unknown, information was requested but not provided.Section d6a.If implanted, give date: unknown, information not provided.Section d6b.If explanted, give date: unknown, information not provided.Section h3: the device was not returned for evaluation as it was discarded; 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.An attempt has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: the following fields were updated based on the additional information received.Section b5: additional information indicated that the replacement lens was a preloaded monofocal intraocular lens, model dib00 of 13.5 diopter.Additional clinical and refractive information was requested; however, the information was not provided.This includes patient functional status prior to explant, visual acuity outcomes, refractive data (preoperative and postoperative), target refraction, and the presence of any pre-existing conditions that could have affected calculation accuracy.No further information was provided.Section d6a.If implanted, give date: (b)(6) 2025 section d6b.If explanted, give date: (b)(6) 2025 (b)(6) section e2: health professional?: yes section e3: occupation: physician corrected data: in review, it was noted that the date of event (apr 22, 2025) was inadvertently entered in the initial mdr report which is incorrect.The information has been corrected in this supplemental mdr report.The following field was updated accordingly: section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2025 and (b)(6) 2025.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: 25355300
• Report Number: 3012236936-2026-000164
• Device Sequence Number: 10612934
• Product Code: HQL
• UDI-Device Identifier: 05050474636033
• UDI-Public: (01)05050474636033(17)261107
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2025
• 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): 06/24/2026

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: DCB00
• Device Catalogue Number: DCB0000175
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2023
• 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