MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BOSTON ADVANCE CLEANER; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Insufficient Information (3190)

Patient Problems Acanthameba Keratitis (1945); Blurred Vision (2137)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Multiple attempts for product information and availability have been made.The status of product availability is currently unknown.Based on all available information, no causal factors can be determined, and no conclusion can be drawn.

Event Description

Initially, an eye care center contacted us regarding the rinsing instructions for boston advance cleaner.The patient cleaned and soaked the lenses in the evening and rinsed the lenses with tap water, then filling the lens with saline solution.The patient visited the office with symptoms of eye pain, light sensitivity, headaches, tearing, and blurred vision.The patient was diagnosed with acanthamoeba keratitis and prescribed tobradex 4 times a day and was advised to temporarily discontinue contact lens wear.The patient visited the office again 22 days later and again was diagnosed with acanthamoeba keratitis.The patient was prescribed alrex and prolensa twice a day.Again, the patient was advised to temporarily discontinue contact lens wear.The patient followed up with the office 3 days after the second visit and received the same diagnosis.The patient was instructed to discontinue alrex and prolensa and was prescribed ocuflox 3 to 4 times a day and lotemax gel to be applied at night.The patient visited the office again 20 days later, at which time a prokera lens was placed on the eye to promote healing.The patient was advised to resume alrex and lotemax twice daily.The patient followed up with the office 4 days later and the prokera lens was removed.The patient was instructed to continue using lotemax.Three days later, the patient followed up with the office and was sent for a second opinion.Ten days later, the diagnosis of acanthamoeba keratitis was confirmed.The patient's current status is unknown.

• Brand Name: BOSTON ADVANCE CLEANER
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 8507 pelham road; greenville SC 29615
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 10867575
• MDR Text Key: 217100348
• Report Number: 0001313525-2020-00170
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K974466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention