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

Catalog Number CBVUNK00093

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

Patient Problems Pain (1994); Visual Impairment (2138); Ulcer (2274)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is unknown.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

As initially reported by health authority via email on (b)(6) 2020, an ophthalmologist reported that on (b)(6) 2020, patient was diagnosed with very painful lower ulcer that caused visual impairment extension despite treatment.Patient was hospitalized and 24 hours eye drops were prescribed.Symptoms resolution is unknown.Additional information has been requested but not yet available.

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).

• Brand Name: AIR OPTIX UNSPECIFIED
• 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: 11096932
• MDR Text Key: 224529684
• Report Number: 9681121-2020-00007
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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 Catalogue Number: CBVUNK00093
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other