MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; EXTENDED DEPTH OF FOCUS 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 Impairment (2138); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
The pre-loaded dxr00v model intraocular lens (iol) was implanted in the patient's eye.Due to complaints of power miss, the iol was explanted in a secondary surgical procedure and replaced with a dxr00v 12.0 diopter iol.The patient also had complaints of halos and blurry vision that she could not adapt to.The following are all unknowns: patient injury, medical intervention, and surgical intervention.Patient prognosis post lens exchange was reported as doing well now with a visual acuity of 20/25+1 (j1) od and 20/30-1 (j1) os.No further information is available.03-feb-2025 product investigation (b)(4) was completed without device visual inspection and no product deficiency or product malfunction was identified.Results were included in the initial report submission.
Additional Manufacturer Narrative
Additional information: section b-3: date of event: unknown/asked information was not provided.The best estimation date is between (b)(6) 2024 and (b)(6) 2024 (iol implant and explant dates).Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.Device evaluation: product evaluation was not performed because the product has not been received.If product is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.The manufacturing records for the product were reviewed, the units were released in accordance with specifications.The search revealed that no other complaints were received for this production order (po) number.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issues reported could not be confirmed and no product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 21332648
• Report Number: 3012236936-2025-000033
• Device Sequence Number: 8604015
• Product Code: POE
• UDI-Device Identifier: 05050474761650
• UDI-Public: (01)05050474761650(17)250515
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 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): 02/07/2025

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: 05/15/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU130
• 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: 01/13/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2022
• 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