MAUDE Adverse Event Report: CIBA VISION STERILE MFG (CA) AQUIFY; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796)

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.(b)(4).

Event Description

As initially reported by an eye care professional thru email, a consumer experienced a past bacterial corneal ulcer in the right eye associated with the reported complaint products.No information regarding medication and treatment modality was provided.The event resolved.No further information can be obtained.

Manufacturer Narrative

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.(b)(4).

• Brand Name: AQUIFY
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): CIBA VISION STERILE MFG (CA); 6515 kitimat road; mississauga, ontario L5N 2 X5; CA L5N 2X5
• Manufacturer (Section G): CIBA VISION STERILE MFG (CA); 6515 kitimat road; mississauga, ontario L5N 2 X5; CA L5N 2X5
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7106079
• MDR Text Key: 94478675
• Report Number: 8020392-2017-00007
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 02/23/2018
• 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): Other