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	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that preloaded monofocal intraocular lens (iol) was explanted due to photopsia.The lens was removed and replaced during a secondary surgical procedure with another company¿s iol.No injury or additional intervention was required.The patient is doing well.The pre-visual acuity was 20/30-2, and the post-operative visual acuity is recorded as 20/30-1.No further information is available.
Additional Manufacturer Narrative
Section a3, a4 and a5: unknown/ not provided.Section h3: the device was not returned for evaluation.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.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: device date returned to manufacturer: sept 29, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device revealed that the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected, and no issues were identified.The complaint issues were not identified during product evaluation.The other observed issues could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specification.No product deficiency or product malfunction could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that two (2) additional complaints were received for this po.No escalation required.Conclusion: based on the complaint investigation results, no product deficiency or product malfunction were found.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: 23069806
• Report Number: 3012236936-2025-000238
• Device Sequence Number: 9738739
• Product Code: HQL
• UDI-Device Identifier: 05050474635968
• UDI-Public: (01)05050474635968(17)260922
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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 Expiration Date: 09/22/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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 Age: 47 YR
• Patient Sex: Female