MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED RENU FRESH MULTI-PURPOSE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

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

Patient Problems Corneal Scar (1793); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

The complaint sample was not returned for evaluation and its lot number was not provided.While some details in the social media post suggest that this could have been a more serious event, the description did not identify any lens or lens care products being used at the time of the event.Several attempts to contact the author of the social media post have been unsuccessful.At this time, the manufacturer is neither able to confirm the accuracy of the report nor the circumstances surrounding the presumed event.Consequently, based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A consumer reported via one of the manufacturer¿s social media sites that she experienced a mucopurulent ocular event years ago that required hourly topical ophthalmic treatments and resulted in a corneal scar.Consumer reported being warded at an unspecified hospital for approximately one week relevant to this event.Additional information has been requested but has not been received.

• Brand Name: RENU FRESH MULTI-PURPOSE SOLUTION
• 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: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 6823764
• MDR Text Key: 83772355
• Report Number: 0001313525-2017-02739
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K020802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• 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?: No
• Date Manufacturer Received: 08/11/2017
• 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): Hospitalization; Required Intervention