MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92000509

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

Patient Problems Corneal Ulcer (1796); Erythema (1840); Unspecified Infection (1930); Irritation (1941); Pain (1994); Swelling (2091)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.(b)(4).

Event Description

As initially reported by a consumer through email on (b)(46 2018, the consumer had recurrent bacterial infection which led to ulcerations, specifically affecting her right eye only, with the use of the set of contact lenses that she purchased dated (b)(6) of 2018.The consumer detailed that she has tried using 3 different contact lenses from the same set, using them not longer than 2 weeks and still experienced the same signs and symptoms on the right eye.The consumer stated that the infection was extremely painful that it had affected her adl.She also claimed that the recurring infection had resolved only after using an expensive unknown medication with unknown treatment modality prescribed by her eye care provider (ecp).Received additional information from the consumer through email on (b)(6) 2018 stating that initial redness on her right eye occurred on (b)(6) 2018 after wearing a pair of contact lenses from her 6-month supply.The redness and irritation subsided almost completely after the consumer stopped using the contact lenses.The consumer added that she had not worn contact lenses for almost two weeks after the initial symptoms.When she decided to use contact lenses again, she had utilized a new pair from the same pack.After about a week of wearing the said contact lenses, the consumer felt eye irritation again.The second occurrence was dated (b)(6) 2018 where the consumer opted to seek medical advice immediately due to severe pain alongside with redness and swelling.The consumer¿s eye care professional (ecp) diagnosed her with two corneal ulcers in her right eye.The consumer was then given ciprofloxacin hcl ophthalmic antibiotic solution with an unknown treatment regimen and was advised to rest her eyes and discard the remaining contact lenses and other eye-care products that came in contact with the infected eye to prevent contamination.The consumer elected to use the third pair of contact lenses again after not even a week of wearing them.She then mentioned that the third occurrence happened on (b)(6) 2018 where she again experienced pain, redness and swelling prompting her to seek medical attention immediately.The ecp then diagnosed her to have corneal ulcers again.She was then prescribed with another unknown ophthalmic solution with unknown treatment regimen.The consumer affirmed that she takes care of her contact lenses.She also added that the issue occurred with three different lenses and all from the right contact lenses of the same pack and that the contact lenses were not torn.The symptoms she experienced were resolved when the contact lenses were removed and subsided with the help of prescription ophthalmic solutions.The consumer also stated to have resumed contact lens wear and have not experienced any issue or infection at all.Received additional information from the eye care provider (ecp) through email on (b)(6) 2018.The ecp stated the consumer had recurring corneal ulcer in the right eye, which required the consumer to undergo eye treatment regimens in the past few months.The ecp explained that the eye condition would fully resolve every after the consumer adheres to the treatment regimen but however would come back upon wearing contact lenses.Lastly, the ecp added that the consumer experienced irritation or abrasion to the right eye leading to the recurrent ulcers.

Manufacturer Narrative

This is the first of two reports for the same consumer involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the reported second lot number 31308608.The complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• MDR Report Key: 7892894
• MDR Text Key: 120827135
• Report Number: 9681121-2018-00009
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: CBV92000509
• Device Lot Number: 31314054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other