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	Flashers (1864); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the doctor that a 3-weeks post op patient with a symfony optiblue intraocular lens (iol) was experiencing significant starbursts at night to the point where she does not want to drive.The patient was essentially plano and with an auto refractor, she was -0.75 as expected.The oct (optical coherence tomography) is clear, tomography shows little cylinder and no signs of dry eye.The patient was given some tears and even though pupil was normal sized, the patient was given some vuity eye drops and was asked to give it for another 3 weeks.The patient¿s near or intermediate vision was ok but a little less than expected which could be the reason for the refraction being slightly plus.The doctor was hoping to avoid an exchange.Additional information received stated that the doctor had removed the symfony lens from the patient and it was replaced with a competitor lens.There were no complications with the exchange including no vitrectomy or suture.They do not have the lens and the lens is not being returned.No further information is available.
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2023.Section d6b: if explanted, give date: unknown, not provided, but the best estimate date is between (b)(6) 2023.Section h3: other 81: the device was not returned for evaluation as the lens is not available for return.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation 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.

• 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: 18149861
• Report Number: 3012236936-2023-02885
• Device Sequence Number: 12186777
• Product Code: POE
• UDI-Device Identifier: 05050474761810
• UDI-Public: (01)05050474761810(17)250409
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/16/2023

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: 04/09/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU210
• 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: 10/20/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2022
• 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 Age: 69 YR
• Patient Sex: Female