MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92003420

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

Patient Problems Corneal Ulcer (1796); Irritation (1941); Keratitis (1944)

Event Type  Injury  

Manufacturer Narrative

The complaint sample has been 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 distributor on (b)(6) 2018 via personal communication, a male consumer had experienced irritation after contact lens wear.He sought medical attention on (b)(6) 2018 and was diagnosed with an unspecified corneal ulcer and keratitis.The consumer was prescribed with tobramycin eye drops and erythromycin ophthalmic ointment with an unknown dose and frequency.He visited his eye care specialist again last (b)(6) 2018 and confirmed that the symptoms did not subside.The consumer's eye status was unknown.Laboratory tests and further medical visits were not disclosed.As of (b)(6) 2018, the ecp confirmed that the symptoms were alleviating.As of (b)(6) 2018, additional information was received which had confirmed that on (b)(6) 2018 the consumer experienced keratitis in the right eye only located at 11 o'clock which was treated with ofloxacin ophthalmic solution with an unknown dose and frequency.It was also indicated that the consumer was diagnosed with corneal ulcer in the left eye only located at 11 o'clock with a visual acuity of 1.2 or almost equal to 20/16.6 after (b)(6) 2018.He was given ofloxacin and tobramycin antibacterial eye drops which was both applied eight times per day and erythromycin antibiotic eye ointment which was applied three times a day to treat the ulcer.It was also specified that the consumer¿s eye status had improved as of (b)(6) 2018.Further information cannot be obtained as consumer refused to provide more details.

Manufacturer Narrative

The complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.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

Correction: h.2,b.5 upon further review of this case, the complaint does not meet criteria as a serious adverse event based on information provided by the consumer and healthcare provider when follow up was performed.The manufacturer internal reference number is: (b)(4).

Event Description

The healthcare provider reported and diagnosed a consumer with left eye peripheral corneal ulcer.The healthcare provider also confirmed that during follow up, the severity was non serious and that the outcome had improved with a visual acuity of 1.2 almost equal to 20/16.6.No further details provided.

• Brand Name: AIR OPTIX AQUA MULTIFOCAL
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• 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: 8170985
• MDR Text Key: 130619149
• Report Number: 3006186389-2018-00047
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: CBV92003420
• Device Lot Number: 10319722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other