MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLCTY TECNIS SYMF ERV OB; INTRAOCULAR LENS

Model Number	DXR00VU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: unknown/asked but unavailable.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, 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.(b)(4).Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient had a hyperopic surprise (+1.25) and negative dysphotopsia with an intraocular lens (iol).Therefore, the lens was explanted from the patient's right eye.The surgeon reported the patient is doing fine and does not feel this was any fault of the lens.The surgeon commented it was quite remarkable that the patient's vision was still 20/25 uncorrected even with such a hyper surprise and it shows it's true edof (extended depth of focus intraocular) benefits.Through follow-up, it was learned that another johnson & johnson ar40e lens (different model and 21.0 diopter) was implanted as a replacement.The explanted lens was discarded.Pre-operative (op) uncorrected visual acuity (ucva) was: ucva 20/200, 20/80.Post-op ucva 20/20 -2 (1 day), 20/25 +1 (1 week), bcva (best-corrected visual acuity) with mr (manifest refraction) 20/20.There was no patient injury.A capsular tension ring (ctr) was used during surgery as the surgeon uses them frequently (as a standard of care to give stability) because the patient has phacodenesis.The patient's post-operative outcome reported ucva 20/50 (1 day) glare & halos/light sensitivity.1 week post op visit was scheduled for (b)(6) 2022.There was no reported patient injury.No additional information was provided.This report captures dxr00v lens.The replacement lens is not a reportable issue.

• Brand Name: TECNIS SIMPLCTY TECNIS SYMF ERV OB
• 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: 14860691
• Report Number: 3012236936-2022-01651
• Device Sequence Number: 17345342
• Product Code: HQL
• UDI-Device Identifier: 05050474761803
• UDI-Public: (01)05050474761803(17)250410
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/29/2022

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: 04/10/2025
• Device Model Number: DXR00VU
• Device Catalogue Number: DXR00VU205
• 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: 06/03/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White