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

Catalog Number CBV92037121

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Corneal Ulcer (1796)

Event Date 09/01/2020

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

Initial report was received from sales representative via telephone on (b)(6) 2021, reportedly after wearing lens the patient had experienced corneal ulcer and had hospital treatment.The patient was not continuing with contact lens wear.Symptoms resolution was unknown.

Manufacturer Narrative

Additional information has been updated in b5 field.Based upon further review of this case, the complaint does not meet criteria as a serious adverse event based on information provided when follow up was performed.The manufacturer internal reference number is: (b)(6).

Event Description

Additional information was received on 25feb2021, it was confirmed that, the ulcer was located on the right superior cornea, around 11 o'clock position.No culture tests available.Based on the available information and rdsop 10011 case has been downgraded to non-serious.This complaint is no longer considered serious or reportable.

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned 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

Additional information was received on 18feb2021, states that on an unspecified date in (b)(6) 2020, patient experienced discomfort, pain and watery eye (right).On (b)(6) 2020 the patient sought medical attention and was diagnosed with corneal ulcer.Patient was treated with unspecified eye drops and symptoms resolved.

• 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: 11320593
• MDR Text Key: 231653748
• Report Number: 9610813-2021-00003
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

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: 01/31/2024
• Device Catalogue Number: CBV92037121
• Device Lot Number: N1178418
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/17/2021; 02/25/2021
• Supplement Dates FDA Received: 02/24/2021; 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other