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

Catalog Number CBV92037121

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

Patient Problems Corneal Ulcer (1796); Irritation (1941); Occlusion (1984); Pain (1994); Discomfort (2330)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

The complaint product was returned for evaluation and was found to meet manufacturing specifications.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).

Event Description

It was reported that a consumer experienced corneal ulcer from the use of the complaint contact lenses.Additional information was received on 10aug2019 via email.It was reported that the consumer experienced difficulty on putting on the contact lenses in the left eye (os) as well as strong irritation on the eye.The problem occurred with more than 20 contact lenses and removal of the contact lenses resolved the issues.The consumer sought medical attention on (b)(6) 2019 and was diagnosed with corneal ulcers.The consumer was treated with unspecified occlusion, epithelialization and anesthetic.Additional information was received on 14aug2019.It was reported that there was no data for the location of the corneal ulcer.The consumer felt pain which was difficult to describe and the consumer had difficulty opening both eyes.The consumer felt relief after the eye care professional (ecp) applied unspecified drops and a cream.The ecp noted that the eye scarred well after the treatment and revision.Additional information regarding the event was requested from the ecp.On 25jun2020, additional product with a different lot number was received from the ecp.Follow-up with the ecp was unsuccessful in determining the association of the newly reported lot to the event as reported above.No further information is available.

• Brand Name: DAILIES TOTAL 1 MULTIFOCAL
• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10326638
• MDR Text Key: 208329970
• Report Number: 9610813-2020-00008
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: CBV92037121
• Device Lot Number: N1171733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2019
• 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
• Patient Age: 55 YR