MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BOSTON SIMPLUS MULTI-ACTION SOLUTION; PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE

Lot Number GF16026

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Conjunctivitis (1784); Corneal Abrasion (1789); Irritation (1941); Pain (1994); Burning Sensation (2146); Eye Burn (2523)

Event Date 08/21/2016

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.A review of the lot batch record and testing of a retain sample concluded this product was formulated, manufactured and packaged according to local and global specifications.The doctor attributes the event to the product.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Consumer reported she is a first time user of the product and had extreme pain after use.Consumer reported visiting an emergency room and was diagnosed with a corneal abrasion and chemical burn.Medical records received from the emergency department indicated patient visited with complaints of bilateral eye irritation and burning.The record notes patient had a mild corneal abrasion and chemical burn from the eye care product.The emergency department contacted poison control who informed the patient's eyes will be uncomfortable until healed, which should be in 24 hours.The emergency room's final diagnosis was agitation and contact lens corneal abrasion.Patient was prescribed erythromycin ophthalmic ointment and instructed to follow-up with her eye care practitioner.Records received from patient's eye care practitioner indicates patient was diagnosed with chemical conjunctivitis.No corneal abrasion was observed and there is no permanent decrease in visual acuity.Patient was treated with artificial tears and cool compresses.Patient's condition resolved.

• Brand Name: BOSTON SIMPLUS MULTI-ACTION SOLUTION
• Type of Device: PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE
• 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: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 6106649
• MDR Text Key: 60029341
• Report Number: 0001313525-2016-00587
• Device Sequence Number: 1
• Product Code: MRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Lot Number: GF16026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR