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

Catalog Number CBVUNK00155

Device Problem Defective Device (2588)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available the manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by sales representative via website on (b)(6) 2020, it was stated by the eye care professional (ecp) that she noted micro aberration while lens fitting, on an unspecified date the patient had experienced corneal ulcers twice due to the lens.Ecp could not confirm the association of the event with lens fitting.No medical intervention is required.Symptoms resolution was unknown.Additional info has been requested but not yet available.

Manufacturer Narrative

H.3., h.6.: 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).

• 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
• MDR Report Key: 10875166
• MDR Text Key: 217328227
• Report Number: 9610813-2020-00013
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K182902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other