MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS

Lot Number H14123-1215

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 06/01/2017

Event Type  Injury  

Event Description

Clear care plus with hydraglyde causes extreme dryness and pain upon insertion of lenses cleaned with it into eyes.This happened repeatedly before i discontinued use of this product.Is the product over-the-counter: yes.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.Why was the person using the product: allegedly cleans contact lenses.

• Brand Name: CLEAR CARE PLUS
• Type of Device: CLEAR CARE PLUS
• Manufacturer (Section D): ALCON
• MDR Report Key: 6621475
• MDR Text Key: 77218308
• Report Number: MW5070239
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2018
• Device Lot Number: H14123-1215
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 90