MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX PLUS HYDRAGLYDE; EXTENDED WEAR SOFT CONTACT LENS

Catalog Number CBV92037094

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Erythema (1840); Ulcer (2274)

Event Date 03/18/2019

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.(b)(4).

Event Description

As initially reported by the patient on (b)(6) 2019 via telephone informing that the contact lens presented a problem.The patient had been wearing this type of contact lens for a year and that she was experiencing issues.The patient informed that she had an unspecified ulcer in the eye when she used the contact lenses.She sought medical treatment and was treated with an unspecified eye drop one drop daily without using the contact lenses for two months.The patient used another contact lens and her eye was red.The patient's eye condition was reported as unknown.Additional information has been requested but not yet received.

Manufacturer Narrative

Device evaluated by mfr: the complaint product was not returned and product malfunction could not be confirmed.Product manufacturing history records were reviewed and met release criteria.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.Evaluation on retain sample found product was meeting manufacturing specifications and there was no sign of leakage observed in the 12 pieces of lenses.No abnormality of internal trending identified during this investigation review.The root cause could not be determined.The manufacturer internal reference number is: 2019-20062.

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE
• Type of Device: EXTENDED WEAR SOFT CONTACT LENS
• Manufacturer (Section D): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• MDR Report Key: 8508846
• MDR Text Key: 141767008
• Report Number: 3006186389-2019-00006
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: CBV92037094
• Device Lot Number: 10339087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other