MAUDE Adverse Event Report: CIBA VISION GMBH PRECISION1 LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00155

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

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Event Description

A doctor reported that a consumer experienced corneal ulcer after wearing contact lenses. The current status of the consumer's eye is not known at the time of this report. Additional information has been requested but not yet received.

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation. A dhr of the production information of the investigated lot could not be conducted. A relationship between the device and the reported incident or adverse event could not be established at this time. A root cause related to our product could not be determined. The manufacturer internal reference number is: (b)(4).

• Brand Name: PRECISION1
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer (Section G): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 12932868
• Report Number: 9610813-2021-00018
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CBVUNK00155
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Outcome(s): Other