MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92000509

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

Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Excessive Tear Production (2235); Discomfort (2330)

Event Date 12/31/2020

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.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 the second report filed under the manufacturer internal reference number of (b)(4) for the reported lot number 31393807.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by a health care professional, a consumer had been experiencing discomfort, red eye and tearing in the left eye (os) which resolved with removal of the contact lenses.The consumer visited the ophthalmologist and was diagnosed with a corneal ulcer in the os.The use of contact lenses was suspended for three months and consumer recovered from ulcer on (b)(6) 2021.The consumer resumed contact lens wear and experienced a new "lesion" in the os, which was treated with a combination of gatifloxacin 0.3% one drop a day for fifteen days and dexamethasone 0.1% for ten days.The current status of the consumer¿s eye is recovered.Additional information has been requested, but not yet received.

Manufacturer Narrative

Based on the additional received following submission of the initial report this event is no longer considered serious or reportable as the event occurred in the left eye.Additional reports for the left eye and suspect product lot will be submitted under manufacturing report number 9681121-2021-00004.

Event Description

Additional information was received indicating the reported device for this event was used in the right eye, however, the corneal ulcer occurred in the left eye.

• Brand Name: AIR OPTIX FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• MDR Report Key: 12553386
• MDR Text Key: 273982814
• Report Number: 9681121-2021-00003
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: CBV92000509
• Device Lot Number: 31380990
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR