FDA Adverse Event
Injury
Summary report: N
HYDROGEN PEROXIDE CONTACT SOLUTION, 3%
MDR report key: 4888341
·
Received June 28, 2015
Report
- Report Number
- MW5043462
- Event Type
- Injury
- Date Received
- June 28, 2015
- Date of Event
- June 28, 2015
- Report Date
- June 28, 2015
- Manufacturer
- WALGREENS
- Product Code
- LPN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(6) HYDROGEN PEROXIDE CLEANING AND DISINFECTING LENS CARE SYSTEM MADE MY EYES BURN WHEN IN PUT MY CONTACTS IN AFTER USE. I AM CONFIDENT I USED THE PRODUCT CORRECTLY BECAUSE I READ THE DIRECTIONS AND I HAVE BEEN USING CLEAR CARE (THE BRANDED VERSION) FOR ABOUT A YEAR. I PUT IN THE PROPER AMOUNT OF SOLUTION AND LET THE CONTACTS SIT FOR MORE THAN 6 HOURS. IT WAS A 2-PACK ITEM # (B)(6) LOT #132712 WITH EXPIRATION 02-2018. I THINK THEY FAILED TO GET THE CHEMICAL REACTION CORRECT WITH THEIR CASES AND THE SOLUTION. DATES OF USE: (B)(6)2015 - (B)(6) 2015. EVENT ABATES AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417262 | HYDROGEN PEROXIDE CONTACT SOLUTION, 3% | HYDROGEN PEROXIDE CONTACT SOLUTION, 3% | LPN | WALGREENS | 132712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | OTC MEDS: VITAMIN |