MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

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

Patient Problems Visual Disturbances (2140); Discharge (2225); Halo (2227)

Event Type  Injury  

Manufacturer Narrative

If explanted, give date: not applicable, remains implanted in the eye.The device was not returned for analysis as the lens remain implanted in the eye.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 by a patient who underwent bilateral intraocular lens (iol) implants.She is now experiencing visual disturbance, sensitivity to light and itchy eyes.Further information provided states she is sensitive to all digital light, led, spotlight, and traffic lights.She also notices some color change, brown pants looked purple to her, and meat looks fresh, but after brought home it looked brown.She finds her eyelids are always sticky.During the day she is more sensitive, and her eyes get very itchy, so she wears sunglasses.If she looks very straight at the right side, she will an arrow go into her eye that is very painful so she must turn her head back to the center which might be a nerve issue.Daytime was worse before surgery and now nighttime is worse.Additional information received reported that patient has astigmatism, halos and glare which she did not have prior to surgery.She is also seeing something shiny in the corner in her eye on the nasal side, like aluminum.Additionally, since surgery her eyes are producing a discharge which causes discomfort.The patient wears sunglasses which helps subside the symptoms including when she is outside at night.She has also been told she is now farsighted whereas before she wasn¿t.No additional information was received.This mdr is for the right eye.A separate mdr has been submitted for the 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• 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: 9072516
• MDR Text Key: 159518868
• Report Number: 2648035-2019-01010
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)210130
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• 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