MAUDE Adverse Event Report: PT. CIBA VISION BATAM UNKNOWN CONTACT LENS

Lot Number ASKU

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

The device was not available for evaluation.The lot number was not provided.The manufacturing investigation is still 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

It was initially reported by a consumer that he was advised by an eye care provider (ecp) to discontinue contact lens wear due to an unspecified surgery on the eyelid and tear duct.It was also reported that contact lens wear had ceased prior to surgery due to a series of non-specified "inflammations", for which the surgery was indicated.It was reported that the patient was hospitalized.Post-surgery treatments included unspecified antibiotics and eye drops, for which the consumer is no longer using.It is reported that the consumer's condition is good, and he will follow-up with the ecp in 01(b)(6) 2016.Additional information has been requested but not yet received.

Manufacturer Narrative

The manufacturing investigation did not indicate that this complaint was due to the manufacturing process.No adverse complaint or manufacturing trend was identified.The root cause could not be determined.(b)(4).

• Brand Name: UNKNOWN CONTACT LENS
• Type of Device: UNKNOWN CONTACT LENS
• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5379267
• MDR Text Key: 36396580
• Report Number: 9681121-2016-00004
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

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 Lot Number: ASKU
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention