MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLCTY TECNIS SYMF ERV OB; 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); Vitreous Floaters (1866); Visual Disturbances (2140); Halo (2227)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: 81: the device was not returned for analysis.Therefore, a visual analysis of the complaint device cannot be completed.A review of the device history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the dxr00v 19.5 diopter intraocular lens (iol) was implanted into the patient¿s operative eye.Iol was explanted in a secondary surgical procedure due to complaints of dysphotopsias, spiderwebbing, and haloes/starburst when seeing lights at night while driving.Patient does not feel comfortable driving at night.Pre-operative vision: 20/25 and post-operative vision: j2, 20/60.There was no incision enlargement, no suture(s), and no vitrectomy.Patient was prescribed medication.Through follow-up additional information was received stating dxr00v iol was replaced with a non-johnson & johnson surgical vision lens.Patient status after dxr00v explant was confirmed as still temporarily impaired.No further information is available.

• Brand Name: TECNIS SIMPLCTY TECNIS SYMF ERV OB
• 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: 16185322
• Report Number: 3012236936-2023-00126
• Device Sequence Number: 11335128
• Product Code: POE
• UDI-Device Identifier: 05050474761780
• UDI-Public: (01)05050474761780(17)250331
• 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: 2022
• Device Explanted Year: 2022
• 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): 01/17/2023

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: 03/31/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU195
• 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: 12/20/2022
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female