MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED SENSITIVE EYES PLUS SALINE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

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

Patient Problems Bacterial Infection (1735); Irritation (1941); Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146); Excessive Tear Production (2235); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Additional event information has been requested but has not been received.The lot number was not provided.Social media comments originating from the post revealed that the solution in question was expired, though the date was not provided.With controlled manufacturing process and in-process quality monitoring, it is unlikely that the ant infestation occurred while the product was in the manufacturer¿s control.Consumer procedural activity that may have contributed to the infestation is unknown.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A consumer reported in a social media post that she has worn lenses for years without any problems other than normal irritations that happen from time to time.The consumer indicated that a week prior to the post, her eyes were hurting, non-stop watering, burning and bloodshot.According to the consumer, she made an appointment to go to the eye doctor immediately, the doctor diagnosed her with a bacterial infection with severe irritation and swelling, and the doctor prescribed steroid eye drops to be used every 4 hours for 10 days.The consumer also stated that she has been placed on 3 different types of prescription eye drops daily, in addition to oral antibiotics.The post included several pictures of the right eye wearing a contact lens.A photo had diffuse temporal bulbar injection that was several millimeters from encroachment on the lens edge or limbus.Another photo had diffuse nasal injection that encroached on the lens edge and limbus.The nasal photo appeared to have a sub-conjunctival hemorrhage with blood pooling at the lens edge.The inferior bulbar conjunctiva did not exhibit diffuse injection similar to that noted temporal and nasal.The superior bulbar conjunctiva was not visible in the photos.The consumer also reported that, when cleaning her contact case and contacts, she noticed something on the contact.The consumer stated that she cut the bottle of solution open and noted it was infested with ants.The consumer post also included pictures of a cut bottle with ants in the solution.Several messages have been sent to the consumer to obtain additional details about the event.The consumer has not responded to the messages and the consumer post has been deleted from the consumer's page.

• Brand Name: SENSITIVE EYES PLUS SALINE 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: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7598606
• MDR Text Key: 110995684
• Report Number: 0001313525-2018-00117
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P800024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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: 05/14/2018
• 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): Other