MAUDE Adverse Event Report: COOPERVISION, INC. PROCLEAR MULTIFOCAL TORIC (OMAFILCON B)

Lot Number CV4306908P

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problems Abrasion (1689); Bacterial Infection (1735); Foreign Body In Patient (2687)

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

Patient reported a contact lens tore while in the eye and was unable to remove a piece.The patient was seen for lens removal and indicates the lens caused two abrasions that were treated with antibiotics.The patient later was diagnosed with a (b)(6) infection that was treated with (b)(6).While a (b)(6) is not normally caused by lens wear, and would not be a reportable incident, in this instance, it is likely the trauma from the alleged damaged lens and resulting eye injury likely caused or contributed to the infection.Good faith efforts have been made to obtain additional information regarding the injury, medical treatment provided, and outcome.This incident is being reported in an abundance of caution due to the potential relationship with lens use, lack of medical information, and unknown outcome.

Manufacturer Narrative

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

Event Description

Received additional medical information from the treating eye care provider.Patient was experiencing a foreign body sensation and eye pain of the right (od) eye; a torn lens was removed from the conjunctival sac and patient was diagnosed with a corneal abrasion with no evidence of infection or dehiscence.Patient was prescribed ocuflox.At follow-up on patient was diagnosed with anterior uveitis, patient instructed to continue use with ocuflox and was prescribed zirgan and acyclovir.At follow-up patient was diagnosed with herpes simplex in the right (od) eye.At the next three follow up visits, it was documented patient's symptoms continued to improve.As of (b)(6) 2017 eye care provider indicates the incident has fully resolved.

• Brand Name: PROCLEAR MULTIFOCAL TORIC (OMAFILCON B)
• Type of Device: PROCLEAR MULTIFOCAL TORIC (OMAFILCON B)
• Manufacturer (Section D): COOPERVISION, INC.; 711 north road; scottsville NY 14546
• Manufacturer (Section G): COOPERVISION, INC.; 711 north road; scottsville NY 14546
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 6367653
• MDR Text Key: 68609915
• Report Number: 1314956-2017-00003
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Lot Number: CV4306908P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR