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

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was unhappy and did not adjust well to the preloaded multifocal intraocular lens (iol), model dxr00v that was implanted.The patient reported experiencing moderate to severe blurred vision, photophobia, and glare of the left eye.The patient did not show improvement over several months which led to the decision to have the lens explanted by another surgeon at a different surgery center.The complaint device is discarded.No additional information provided.
Additional Manufacturer Narrative
Section a4, a5, and a6: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is after dec 5, 2024.Section d6b: if explanted; give date: unknown, information was requested but not provided.Section h6: health effect - clinical code: 2140 photophobia, 2140 glare surgical intervention required.Device evaluation: the product testing could not be performed as the product was not returned for evaluation (the lens was discarded).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint was received for this po.Although these complaint issues reported are related, the issue could not be confirmed as related to manufacturing.Therefore, no further actions are required.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Attempts have been made to obtain missing information; however, to date, the information has not been provided.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: 23399232
• Report Number: 3012236936-2025-000279
• Device Sequence Number: 13248295
• Product Code: HQL
• UDI-Device Identifier: 05050474761803
• UDI-Public: (01)05050474761803(17)270830
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: DXR00V
• Device Catalogue Number: DXR00VU205
• 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: 10/15/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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 Age: 75 YR
• Patient Sex: Male