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	Visual Disturbances (2140)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after implantation of a preloaded monofocal intraocular lens (iol), the patient experienced a "shadow on the left" in their peripheral vision.The issue did not interfere with the patient's daily activities.The lens was explanted during a secondary surgery, and the patient recovered fully without the need for unplanned surgical interventions.A non-johnson & johnson lens of 21.5 diopter was used as a replacement iol.No medication outside of standard of care was required and no patient injury was reported.It was noted that the directions for use of the device were followed.No further information was provided.
Additional Manufacturer Narrative
Section h3: the device was not returned for evaluation; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: oct 6, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was cut into three pieces and coated in viscoelastic residue.The lens pieces were cleaned revealing a scratch.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other issues observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.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.

• 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: 22891175
• Report Number: 3012236936-2025-000225
• Device Sequence Number: 8984652
• Product Code: HQL
• UDI-Device Identifier: 05050474636132
• UDI-Public: (01)05050474636132(17)270204
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: DCB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2024
• 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 Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White