MAUDE Adverse Event Report: CIBA VISION GMBH DAILIES TOTAL 1; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00077

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

Patient Problems Unspecified Infection (1930); Keratitis (1944); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.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

It was initially reported on (b)(46 2018 by a consumer via website that the contact lens has caused an ulcer on unspecified eye site.The consumer has her affected eye covered for four days together with unspecified eye drops and wearing of sunglasses as a treatment.It was also reported that the consumer has been using contact lenses for years without any problem but did not expect that with disposable daily contact lens will caused her damage.At the time of the report, the consumer's eye status is unknown.Further information was received on (b)(6) 2018 from the consumer.The consumer reported that she visited an ophthalmologist who confirmed an infectious ulcer in her eye which was caused by keratitis.She also mentioned that it could be due to her pre-existing dry eye.As a treatment, the consumer was prescribed with an unspecified antibiotic and moisturizing solution with unspecified treatment modality and to be continued even after the event's resolution.It was also reported that the consumer has resumed to contact lens wear.The consumer also added that the event may not be related to contact lens used as it was caused by her pre-existing condition.She also expressed her dissatisfaction with the product used.At the time of the report, the consumer's eye status has resolved.As per information added on 07sep2018, the consumer's injury was due to her pre-existing dry eye and thought the contact lens was not related to the event.Thus, no additional information can be obtained from the consumer.

• Brand Name: DAILIES TOTAL 1
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer (Section G): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7897394
• MDR Text Key: 120989901
• Report Number: 9610813-2018-00023
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00077
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other