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

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

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

Neither consumer contact information nor additional event details are available to the manufacturer.The complaint sample was not returned for evaluation and lot information is unknown.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

The manufacturer obtained the following information on monday, february 4th, 2019 while conducting a search of the (b)(6) database: in 2009, a consumer reported to (b)(6) that they experienced altered visual depth perception, application site vesicles, corneal disorder, impaired driving ability, impaired work ability, vision blurred, and visual impairment after using the complaint product.No treatment information was provided.At the time of the consumer¿s reporting they indicated that they had not recovered and that the incident resulted in an unspecified disability.Current outcome is unknown.

• 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: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 8339036
• MDR Text Key: 136127918
• Report Number: 0001313525-2019-00035
• Device Sequence Number: 1
• Product Code: MRC
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K024289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability
• Patient Age: 45 YR