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

Lot Number 222

Device Problem Insufficient Information (3190)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Corneal Clouding/Hazing (1878)

Event Type  Injury  

Manufacturer Narrative

This event occurred in the united kingdom where this device has been voluntary recalled.The device involved in this voluntary recall has not been distributed to the us.The product was returned and is expired.Evaluation will not be performed as testing of expired product cannot be reliably used to determine a root cause for the reported event.The review of the manufacturing process, quality systems, and product characteristic, and analysis of adverse events, complaints and problems supports the products are safe and performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A patient reported that they experienced damage to their cornea after using a contact lens cleaning solution.Prior to being seen by a doctor the patient experienced a sharp pain, blurred vision and irritation in their left eye.The patient was seen on the next day and during the examination, the doctor observed bulbar injection and corneal edema in the left eye.Corneal staining and a corneal ulcer were both present in the superonasal quadrant of the left eye.The doctor noted that the patient could possibly have microbial keratitis.A corneal scar and minimal corneal haze located close to the pupil of the left eye were also noted during the exam.The patient was diagnosed with possible bacterial corneal ulcer and map dot fingerprint syndrome.That same day the patient was seen by another doctor.During the examination the doctor observed 1.4mm x 2mm epithelial defect with possibly a minimal hypopyon, there was no obvious infiltrate.The patient was prescribed exocin (hourly, night and day) and cyclopentolate 1%.A normal bacterial swab of the lens case was taken and concluded that there was no growth after two days of incubation and no pathogenic organisms isolated.The patient was seen approximately two weeks later and at that time was diagnosed with a left healed corneal ulcer with the anterior stromal scarring.The patient continued with topical antibiotics as well as steroids and lubricants.Approximately one month later the patient was seen for a follow appointment.At the time of this appointment the patient was using dexa free eye drops twice a day and exocin four times a day.A minimal corneal haze scar close to the pupil was observed and there was no evidence of inflammation or epithelial defect.The patient was diagnosed with left corneal scar secondary to contact lens infection, high hyperopia and left corneal astigmatism.The treating doctor recommended the patient wear her glasses or contact lenses and to discontinue all drops.The patient was seen approximately two months later for a follow up appointment.The patient was left with a very small anterior stromal scar in the left eye above the visual axis.The scar has not affected their vision.The doctor feels that the event was caused due to contact lens wear.

• 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-IOM S.P.A; via pasubio 34; 20050 macherio; milan 20846 ; IT 20846
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609
• MDR Report Key: 12562771
• MDR Text Key: 274903649
• Report Number: 0001313525-2021-00122
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• PMA/PMN Number: K974466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2021
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: 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