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

Catalog Number CBV92037097

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Ulcer (1796); Irritation (1941); Pain (1994)

Event Date 07/13/2019

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

It was reported on (b)(6) 2019 that the complaint contact lenses caused a corneal ulcer.Additional information was received on 31aug2019 via email.It was reported that the patient felt irritation on the right eye (od) several days after the purchase of the complaint contact lenses and sought medical attention at an eye department.The patient was diagnosed with corneal ulcer of the od and was treated with an unknown antibiotics, steroid and ocular lubricants.The patient was still ongoing review and was not allowed contact lens wear.On (b)(6) 2019, the patient was reviewed by an optometrist and was prescribed with spectacles.The patient is scheduled for a review after three months.It was reported that the pain and the ulcer were all resolved.

Manufacturer Narrative

One hundred eighty (180) lenses in sealed blisters were returned.All one hundred eighty (180) samples received were all visually inspected and two (2) randomly selected for further testing.Evaluation was performed in accordance with alcon operating procedures.The one hundred eighty (180) sealed samples received were visually inspected for any form of particulate appearance in the solution and there was no indication of any appearance of particulate or foreign body in the solution.Also the two tested samples, sample 1 and sample 2, were found to meet manufacturing specification for package integrity, ph, and osmolality, surface, edge, as well as, base curve and diameter parameters.Based on the results of the samples evaluated, the samples were found to meet manufacturing specification.The examination of lot #n1165981 confirmed that the lot met all specifications.The investigation determined that this lot is acceptable for continued distribution.The contact lenses are manufactured under very high hygiene standards.All employees are trained annually on the hygiene concept and procedures.The verification of the returned samples revealed, samples met specification.No deviations were found during the investigation; no negative product impact could be identified and no root cause could be determined for the reported events.The lot met all specifications.A corrective, preventive action will not be initiated since no issues were identified during the investigation.However, a trend review is conducted on a monthly basis and corrective actions will be determined if required.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 8978493
• MDR Text Key: 161379208
• Report Number: 9610813-2019-00008
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

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: 12/31/2022
• Device Catalogue Number: CBV92037097
• Device Lot Number: N1165981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other