MAUDE Adverse Event Report: ALCON LABORATORIES, INC. UNKNOWN CONTACT LENS CARE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

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

Patient Problem Erosion (1750)

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.This report originally filed as 8020392-2018-00003.The manufacturer internal reference number is: (b)(4).

Event Description

As documented in a literature journal publicized on (b)(6) 2009, there was one case of corneal erosion reported in relation to both the contact lens and the contact lens care product.Since the adverse event was noted from a literature report, additional information can not be obtained.

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).

Manufacturer Narrative

For manufacturing site registration number 1610287, corrected the manufacturing report number to 1610287-2018-00039 from 8020392-2018-00003.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

For manufacturing site registration number (b)(4), corrected the manufacturing report number to 1610287-2018-00039 from 1422160-2018-00003.The manufacturer internal reference number is: (b)(4).

• Brand Name: UNKNOWN CONTACT LENS CARE SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7932101
• MDR Text Key: 122619917
• Report Number: 1610287-2018-00039
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: CORRECTION
• Patient Sequence Number: 1
• Patient Outcome(s): Other