MAUDE Adverse Event Report: BAUSCH AND LOMB BOSTON ONE STEP LIQUID ENZYMATIC CLEANER

Device Problem Off-Label Use (1494)

Patient Problems Itching Sensation (1943); Burning Sensation (2146)

Event Date 04/07/2018

Event Type  Injury  

Event Description

My right eye was itching, so i reached into my bathroom drawer and pulled out what i thought was refresh plus.I squirted the liquid into my eye, and my eye started burning.That's when i realized that i had squirted bausch and lomb boston one step liquid enzymatic cleaner into my eye by mistake.The cleaner is packaged in a disposable plastic tube with twist-off cap that is very similar to the tube for refresh plus.It seems to me that enzymatic cleaner should be packaged in a way that will prevent it being confused for eye drops.Product type: drug/biologic.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.How was it taken or used: ophthalmic.

• Brand Name: BOSTON ONE STEP LIQUID ENZYMATIC CLEANER
• Type of Device: BOSTON ONE STEP LIQUID ENZYMATIC CLEANER
• Manufacturer (Section D): BAUSCH AND LOMB
• MDR Report Key: 7411531
• MDR Text Key: 105151031
• Report Number: MW5076391
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2013
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 66