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

Catalog Number CBVUNK00148

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Scratched Material (3020)

Patient Problems Corneal Abrasion (1789); Eye Infections (4466)

Event Type  Injury  

Event Description

As initially reported by consumer on behalf of her daughter that after wearing the lenses consumer experienced scratch on black part of eye, corneal abrasion and had infection.The consumer was treated with unspecified eye drops as physician suggested.The current status of consumers eye is unknown at the time of the reporting.Additional information has been requested but not yet received.

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.This is the second of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to qs#(b)(4) for the second report.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.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).

Manufacturer Narrative

The additional information regarding the power of the lens has been reported.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.The root cause could not be determined.D.4.: this is the first of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to 2142961 for the reported lot number 31481932.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received, according to which scratching of the eye was caused by the pressure from the suction on lenses that made it difficult to remove from the eye.Consumers also mentioned that the lenses were rough.The current state of consumer eyes is unknown at the time of this reporting.

Manufacturer Narrative

Additional information has been updated in b5 and h6.H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.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).

• 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
• Manufacturer (Section G): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16042257
• MDR Text Key: 306069142
• Report Number: 3006186389-2022-00021
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00148
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female