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

Catalog Number CBV92004051

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

Patient Problem Abscess (1690)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation.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.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by the optician via phone on (b)(6) 2018, a female consumer experienced an unknown event after contact lens wear.Additional information was received on (b)(6) 2018 confirming that the consumer was seen by an ophthalmologist and was diagnosed with an abscess on an unspecified eye location in the month of august.The consumer was given an unidentified antibiotic for three weeks and was advised to discontinue contact lens usage for a month.Following recovery from the adverse event, the consumer developed another abscess after reusing the product in september.The consumer's eye condition, laboratory tests, medical treatment and follow up visits were not disclosed.As of (b)(6) 2018, additional information was received which indicated that the consumer was also diagnosed with an unspecified infection aside from having an abscess on her left eye on two separate occasions, where the first incident happened last (b)(6) 2018 followed by another incident on (b)(6) 2018 while using the same product.She was advised to temporarily discontinue lens wear and was treated twice with tobramycine and ciprofloxacin eye drops and ointment for three weeks.The consumer needed to rest from work for one week and was advised to stay in a dark area for two weeks.The treatment regimen helped resolved the symptoms but had left a scar on the affected eye.Further details has been requested but not received.

Event Description

As of (b)(6) 2018, new information was received which indicated that the specific location of the ulcer and scar is at the peripheral level, temporal side of the eye.The consumer continues to wear her glasses since she had a small permanent scar in her eye with no decrease in visual acuity.It was also added that the medical regimen was given twice according to the date of events.The first event in june, the consumer was given antibiotics for three weeks for her left eye.The second event in september, the consumer was given antibiotics for three weeks on the same eye at a different area.There were no specific laboratory tests done.As of (b)(6) 2018, additional information was received from the optician which had confirmed that the consumer did not use any cleaning products nor any cases since the contact lenses were changed daily.No other data can be obtained.

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.The manufacturer internal reference number is: 2018-76449.

• Brand Name: DAILIES TOTAL 1
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION CORPORATION; 11460 johns creek parkway; duluth GA 30097
• MDR Report Key: 8048241
• MDR Text Key: 126509225
• Report Number: 1065835-2018-00017
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CBV92004051
• Device Lot Number: A5041425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR