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

Model Number	DXW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
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 the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - impact code: 4619 - visual disturbance- dysphotopsia; 4619 - halo vision.Section h6: health effect - impact code: 4625 - additional surgery (unplanned sutures).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the implantation of the preloaded toric intraocular lens (iol) into the left eye, the patient experienced contrast and halo issues and was more reliant on reader glasses.The patient reported that vision had been this way since initial surgery.The issue was first identified during a post-operative examination.It is unknown if there was one or more daily activities that the patient was unable to perform due to this issue.The lens was subsequently explanted in a secondary surgery and replaced with a non-johnson and johnson iol with +25.0 diopter.No unplanned vitrectomy occurred, but unplanned sutures were required to prevent injury due to unstable capsule.There was no patient injury.It is unknown if an incision enlargement was required.The patient did not require additional medical attention and no medication outside the standard of care was prescribed.The patient's pre-operative refraction was 20/30-1 and best spectacle corrected visual acuity (bscva) was 20/30+1.The patient's post-operative refraction with the originally implanted lens was 20/30 and bscva was 20/30.The intended target refraction was -0.30.The patient had a pre-existing condition of horseshoe tear without detachment that affected the calculation.The post-operative refraction after the lens exchange was hand motion.The account attributes the event to the device.Directions for use were followed.The patient has fully recovered.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 6, 2026.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the lens was cut with both haptics detached and missing.No further issues were identified.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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 ; road 402 north, anasco ind. pk; anasco 00610 ; 7142478552
• MDR Report Key: 23986041
• Report Number: 3012236936-2026-000009
• Device Sequence Number: 4578885
• Product Code: HQL
• UDI-Device Identifier: 05050474764286
• UDI-Public: (01)05050474764286(17)260818
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Expiration Date: 08/18/2026
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U265
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White