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 Date 07/28/2021

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 a healthcare professional via email, the consumer experienced three ulcers in the left eye.Symptom resolution was unknown.Additional information has been requested but not yet received.

Manufacturer Narrative

A.1, a.3, b.2, b.3, b.5, and e.1: updated information.Based upon the review of the facts available at this time, this complaint is no longer considered serious or reportable.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received which states that consumer experienced with irritation in her eye for two weeks and sensitivity to light.On (b)(6) 2021 diagnosis confirmed marginal ulcer in left eye.Tobramycin eye drops were prescribed.Events resolved and the consumer has resumed contact lens wear.

• 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: 12447268
• MDR Text Key: 270553837
• Report Number: 9610813-2021-00016
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other