MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; MONOFOCAL IOLS

Model Number ZA9003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date not provided, best estimate is (b)(6) 2019.If explanted; give date: n/a (not applicable).The lens remains implanted.The intraocular lens (iol) is not returning for evaluation as it remains implanted; 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).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the patient can feel the lens, she can not stand the light, and has very itchy eyes post implant of an intraocular lens (iol) in her left eye.The patient stated she does not have allergies, but her eyes are very sensitive.Through follow up, it was learned that the patient is very sensitive to light even at night and must wear sunglasses at night, because the light bothers her while she is reading.The patient stated the itchiness bothered her about 1.5 months after the right eye (second eye) lens implant.The surgeon prescribed her post-operative steroid eye drops that she used for 2 weeks to a month.Then the itchiness of the eye came back.She was prescribed steroid eye drops to use for one more month, and the itchy eye has subsided at this time.Additionally, the patient complains of feeling the edge of the lens and sometimes feels a sharp pain in her eye.The patient is seeing an allergy doctor for further testing.Currently, the lens remains implanted.Patient had bilateral lens implants.This report captures the lens implanted in patients left eye.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa (b)(4).

• Brand Name: TECNIS
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9955999
• MDR Text Key: 187704297
• Report Number: 2648035-2020-00351
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529076
• UDI-Public: (01)05050474529076(17)230814
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other