MAUDE Adverse Event Report: BAUSCH & LOMB BIOTRUE ONEDAY FOR PRESBYOPIACONTACTLENS; LENS, CONTACT, DISPOSABLE

Lot Number 222

Device Problem Insufficient Information (3190)

Patient Problems Corneal Abrasion (1789); Acanthameba Keratitis (1945)

Event Type  Injury  

Manufacturer Narrative

The eye care professional (ecp) suspected the patient used tap water on their contact lenses, and with the open abrasion, bacteria had a way to enter the eye.The ecp does not believe that the bacteria came from the contact lens blister pack.Additional medical and product information has been requested, but not received.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A doctor's office reported that the patient developed a suspected corneal abrasion after wearing contact lenses.The patient was told to discontinue contact lens wear and was referred for a second opinion, however the patient did not go.The patient continued to wear contact lenses and developed an infection, suspected to be acanthamoeba keratitis.The patient is non-compliant with lens case and uses tap water to clean the lenses.

• Brand Name: BIOTRUE ONEDAY FOR PRESBYOPIACONTACTLENS
• Type of Device: LENS, CONTACT, DISPOSABLE
• Manufacturer (Section D): BAUSCH & LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB; unit 424/425, cork road; industrial estate; waterford ; EI
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609
• MDR Report Key: 12191415
• MDR Text Key: 262407044
• Report Number: 0001313525-2021-00099
• Device Sequence Number: 1
• Product Code: MVN
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K132715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR