MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXR00
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: unknown, information not provided.Race/ethnicity: unknown, information not provided.Note: the device was manufactured at the (b)(4) site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 intraocular lens(iol) was explanted from patients right eye in a secondary surgical procedure due to blurriness.There was no patient injury and no medical/surgical interventions such as vitrectomy, incision enlargement or sutures were required.The replacement lens used is a non-johnson & johnson vision lens.The patient was alright at the time of discharge.No further information provided.
Additional Manufacturer Narrative
Additional information received revealed, that patient reported on (b)(6) 2019 having blurry vision.There was no incision enlargement and sutures, but vitrectomy was performed ,during the explant.The patient is doing fine.And also the lens was returned for evaluation.Visual acuity pre- operative: 20/40-1, ((b)(6) 2019); visual acuity post- operative: 20/30-2 j3, ((b)(6) 2019).As a result the following fields have been updated: section b3: date of event: (b)(6) 2019; section d9: device available for evaluation? yes; section d9: returned to manufacturer on: (b)(6) 2021; section h3: device evaluated by manufacturer? yes; section h6: health effect: impact code: 4625.Device evaluation: the complaint lens was received stuck to a piece of foam.Additional documentation was received as well.Visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.And that the lens was returned cut in half.Which is consistent with a lens that was handled, during explant.Furthermore, fibers were observed on the lens.However, this can be attributed to receiving the lens stuck to foam.And therefore, cannot be confirmed to be related to manufacturing.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed.And no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed, that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11181614
• Report Number: 2020664-2021-07001
• Device Sequence Number: 2231616
• Product Code: POE
• UDI-Device Identifier: 05050474579125
• UDI-Public: (01)05050474579125(17)230727
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 07/27/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE, LOT# UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR