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

Catalog Number CBVUNK00155

Device Problem Difficult to Remove (1528)

Patient Problem Cellulitis (1768)

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Event Description

A company representative reported on behalf of a healthcare provider that a consumer using contact lenses for a number of years, could not remove the lens from the eye and continued to wear the lens for a month.The customer did not reach the healthcare provider's office to discuss the issue, and subsequently, developed cellulitis and was hospitalized.It is unknown at this time in which eye the reported issue occurred.Additional information has been requested for this event, however, it has not yet been received.

• 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 ; 8007579780
• MDR Report Key: 14111214
• MDR Text Key: 289258113
• Report Number: 9610813-2022-00006
• 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: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00155
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female