MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92001362

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The actual complaint product has not been received by the verification center 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.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is (b)(4).

Event Description

As initially reported by an eye care provider (ecp), a consumer experienced "very important eye discomfort and pain due to a contact lens tearing during wear, which lead the consumer to seek treatment at an emergent care facility.Further information received from the ecp clarified that the consumer experienced unspecified corneal lesions.Additional information has been requested but not yet received.

Manufacturer Narrative

New information received.(b)(4).

Event Description

Additional information was received from the ecp via letter on 10/10/2017 that the patient, with high myopia, seek medical attention on (b)(6) 2017 and (b)(6) 2017 for the removal of a piece of softhydrophilic residual lens in the conjunctival sac.The patient was reportedly prescribed with tobramycin and celluvisc lubricant on (b)(6) 2017; treatment modality and duration were not reported.It was indicated that the patient has not been seen since her last follow up visit.It was also noted that the patient's complaints were about the quality of the lenses tearing "at placement.".

Manufacturer Narrative

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.(b)(4).

Event Description

As initially reported by an eye care provider (ecp), a consumer experienced "very important" eye discomfort and pain due to a contact lens tearing during wear, which lead the consumer to seek treatment at an emergent care facility.Further information received from the ecp clarified that the consumer experienced unspecified corneal lesions.Additional information from the ecp and the patient received on 09/07/2017 that a (b)(6) year old female patient experienced torn lens upon placement on her right eye.This had caused severe redness, pain, watery eye, discomfort and irritation as half of the lens remained in the eye.It was reported that the patient experienced the adverse events four times in six months that lead her to seek medical attention.It was confirmed that the patient's eye had a scar with corneal lesions which caused eye tearing despite the lens was removed and photosensitivity.The patient was advised to cease contact lens wear, to wear sunglasses due to photosensitivity and was treated with unspecified antibiotics and healing drops.The patient's symptoms was reported to be continuing.Additional information has been requested but not yet received.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by an eye care provider (ecp), a consumer experienced "very important" eye discomfort and pain due to a contact lens tearing during wear, which lead the consumer to seek treatment at an emergent care facility.Further information received from the ecp clarified that the consumer experienced unspecified corneal lesions.Additional information from the ecp and the patient received on 09/06/2017 that a (b)(6) year old female patient experienced torn lens upon placement on her right eye.This had caused severe redness, pain, watery eye, discomfort and irritation as half of the lens remained in the eye.It was reported that the patient experienced the adverse events four times in six months that lead her to seek medical attention.It was confirmed that the patient's eye had a scar with corneal lesions which caused eye tearing despite the lens was removed and photosensitivity.The patient was advised to cease contact lens wear, to wear sunglasses due to photosensitivity and was treated with unspecified antibiotics and healing drops.The patient's symptoms was reported to be continuing.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the ecp on 05apr2018 via phone that the patient had replaced her previous contact lenses with a different brand of contact lenses.

• Brand Name: DAILIES AQUACOMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION CORPORATION; 11460 johns creek parkway; duluth GA 30097
• MDR Report Key: 6847407
• MDR Text Key: 85096713
• Report Number: 1065835-2017-00025
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CBV92001362
• Device Lot Number: A0467627
• Other Device ID Number: 000000000010108993-155671300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Date Manufacturer Received: 04/05/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR