MAUDE Adverse Event Report: CIBA VISION STERILE MFG (CA) CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number E0001545

Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)

Patient Problems Keratitis (1944); Burning Sensation (2146); Eye Burn (2523)

Event Date 02/25/2015

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

It was reported that a consumer experienced a burning sensation after using the solution.The consumer used the solution without the required lens cup and disc.When she removed her lenses from the unneutralized solution, she inserted them and experienced a burning sensation.The consumer went to the eye doctor where she was diagnosed with a chemical burn on the cornea.The consumer stated that the bottle had no red tip, and had no instructions because the solution belonged her son's girlfriend's brother.Additional information received on 02/26/2015 stated that the eye care provider will forward the medical notes from the office visit.Additional information received on 02/27/2015 stated that the bottle information was received.It is noted that the expiry of the solution is 04/2014.It is further noted that the consumer did not use the required lens cup and disregarded the solution's expiry date.Additional information was received on 08/25/2015 from the local affiliate in the form of the translated doctor's notes.It is stated that the consumer got contact lens peroxide in the right eye during non-professional activity.The conjunctiva has injections with marked chemosis and weak superficial punctate keratitis.The iris on both sides with marked defects of pigment epithelium in peripheral iris.The rest of the of the anterior eye segment have negative results.The diagnosis was conjunctival/corneal chemical burns of the right eye.The prescribed treatment included rinsing the eye, and dexa gentamicin drops 5ml n1 in the right eye four times a day for one week, and xailin ha eye drops 10ml four times a day for one week.Additional information received on 12/10/2015 stated that the consumer visited a second doctor.The doctor diagnosed "cornea erosion, iris trans-illumination, corneal injury, changes of the endothal, and sicca-syndrome." the consumer was given "fluropos" eye drops and vita pos ointment.Additional information has been requested but not yet received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A trend related investigation was performed and no trend could be identified.There were no non-conformities or deviations during the manufacturing process which related to the nature of the complaint.No root cause determination could be found in relation to the manufacture of the product; the root cause of the complaint conditions is most likely associated with not following the directions for use.(b)(4).

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): CIBA VISION STERILE MFG (CA); 6515 kitimat road; mississauga, ontario L5N 2 X5; CA L5N 2X5
• Manufacturer (Section G): CIBA VISION STERILE MFG (CA); 6515 kitimat road; mississauga, ontario L5N 2 X5; CA L5N 2X5
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5320095
• MDR Text Key: 34166319
• Report Number: 8020392-2015-00506
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: E0001545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention