MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92012369

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Irritation (1941); Ulcer (2274)

Event Date 11/26/2020

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. The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by a physician via personal communication on (b)(6) 2020, consumer stated that on (b)(6) 2020 the consumer felt irritation when wearing the lens, the consumer removed the lens and found it torn. The consumer visited a doctor on (b)(6) 2020. The consumer was diagnosed with ulcer. Eye-drops (type : antibiotic(tobracin),antibacterial(cravit, tarivid)) were prescribed. The doctor instructed the consumer to come again on (b)(6) 2020. Symptom has not been resolved. Additional info has been requested but not yet available.

• Brand Name: AIR OPTIX NIGHT & DAY AQUA
• 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
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10940974
• MDR Text Key: 219360341
• Report Number: 9681121-2020-00006
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CBV92012369
• Device Lot Number: 31417739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/03/2020 Patient Sequence Number: 1