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	Flashers (1864); Visual Disturbances (2140); Halo (2227)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female.Device evaluated by manufacturer: 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 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.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The dxr00v model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Patient reported complaints of intolerable glare, starbursts, halos, and night time vision.Patient symptoms persisted despite multiple post-operative visits and attempts to optimize the ocular surface, and refractive error, thus the iol was explanted in a secondary surgical procedure and replaced with a zcb00 19.5 iol.During the lens exchange procedure, there was minimal incision enlargement however, there were no complications, no serious patient injury, no sutures, and no vitrectomy.Patient status post lens exchange was reported as great prognosis and visual acuity post-operative week 1 was 20/25 sans correction (sc).The suspect iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 17-nov-2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the lens was received in a medical cup, inside a plastic bag.During a visual inspection, the device was inspected under magnification.The lens was coated in viscoelastic residue.The lens was cleaned and further inspected, and no issues were identified.During the product evaluation it was confirmed that the physical characteristics of the lens matched a dxr00v model lens.The complaint issues could not be confirmed during product evaluation, and no issues were identified.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.A search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po) number ¿ visual disturbance- dysphotopsia- requiring surgical intervention.These complaint issues reported are not related.Based on complaint history review (chr) results, no further actions are required.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 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: 23538336
• Report Number: 3012236936-2025-000299
• Device Sequence Number: 9962039
• Product Code: HQL
• UDI-Device Identifier: 05050474761780
• UDI-Public: (01)05050474761780(17)270909
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: DXR00VU195
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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 Ethnicity: Non Hispanic
• Patient Race: White