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	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: unknown/not provided.Section b3: date of event: unknown/not provided section d6a: if implanted; give date: unknown/not provided.Section d6b: if explanted; give date: unknown/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 the review, if there is any further relevant information a supplemental medwatch will be filed.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.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was implanted and later removed.Additional information received stated that the product was discarded; therefore, not available.No further information was provided.
Additional Manufacturer Narrative
Additional information was received which reported that the lens was placed in the patient's capsular bag without complication but the surgeon noted that the bag was not stable.The surgeon chose to remove the lens during the same procedure to prevent further complication and the patient was left aphakic, with no replacement lens placed.It was noted that the procedure was completed successfully.There was no patient injury and no unplanned surgical interventions or medications outside the standard of care were required.It was noted that the cataract extraction was scheduled with a pars plana vitrectomy and the surgeon always uses sutures.The patient tolerated the surgery well, and no intraoperative complications were noted.There are no planned surgical interventions.It was reported that the lens did not cause or contribute to the event, as the issue was that the patient's capsule was not stable.No further information was provided.Corrected data: based on the additional information received, the johnson & johnson intraocular lens (iol) was removed from the patient's eye due to an instability of the patient's capsular bag, with no patient injury, and it was confirmed that the issue was not due to the device.There is no quality issue with johnson & johnson iol.Therefore, this event is no longer considered reportable and the health effect - clinical code of 1845 (eye injury) that was originally reported on the initial mdr no longer applies.There will no longer be any further reporting under mfr report number 3012236936-2025-0003407.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: 23872123
• Report Number: 3012236936-2025-000340
• Device Sequence Number: 19943019
• Product Code: HQL
• UDI-Device Identifier: 05050474635852
• UDI-Public: (01)05050474635852(17)261009
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2026

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: DCB0000085
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• 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: Unknown