MAUDE Adverse Event Report: COOPERVISION CARRIBEAN CORPORATION BIOMEDICS 55 UV (OCUFILCON D)

Lot Number 12314500021006

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

Analysis cannot be performed.No lenses were returned for evaluation.The association between coopervision lenses and the event is unconfirmed.

Event Description

The patient alleges she experienced eye irritation, she was diagnosed with an eye infection and prescribed lotemax.Good faith efforts have been made to obtain additional medical information without success, additional information is unknown.This event is being reported due to incomplete diagnosis, lack of medical information, and unknown resolution.

• Brand Name: BIOMEDICS 55 UV (OCUFILCON D)
• Type of Device: BIOMEDICS 55 UV (OCUFILCON D)
• Manufacturer (Section D): COOPERVISION CARRIBEAN CORPORATION; 500 road 584; lot 7; amuelas industrial park, juana diaz 00795
• Manufacturer (Section G): COOPERVISION CARRIBEAN CORPORATION; 500 road 584; lot 7; amuelas industrial park, juana diaz 00795
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton 94588 ; 5857569874
• MDR Report Key: 6999095
• MDR Text Key: 90962714
• Report Number: 2640128-2017-00018
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890023
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Lot Number: 12314500021006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other