MAUDE Adverse Event Report: CIBA VISION CORPORATION UNKNOWN CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00090

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Corneal Decompensation (1790); 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 documented in a literature journal publicized on december 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

Product manufacturing site updated to correct product involved.Manufacturer report number corrected and reported under manufacturing report number 1610287-2018-00039; (b)(4).All future follow up regulatory reports will be linked to this updated manufacturing number.(b)(4).

Manufacturer Narrative

Manufacturer report number corrected and reported under manufacturing report number 3006186389-2018-00033; manufacturing site registration number 3006186389 all future follow up regulatory reports will be linked to this updated manufacturing number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Updated d2., f10/h6., h1., and b5., to prevent validation error.Corrected d.3, g.1, and h6,.The file reported under mfg report num 1422160-2018-00003 (follow-up num 2) has incorrect mfg site registration (b)(4) thus updated with correct manufacture site registration (b)(4).All future follow up regulatory reports will be linked to this updated manufacturing number the manufacturer internal reference number is: (b)(4).

Event Description

As documented in a literature journal publicized on december 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.

• Brand Name: UNKNOWN CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION CORPORATION; 333 e. howard avenue; des plaines IL 60018
• Manufacturer (Section G): CIBA VISION CORPORATION; 333 e. howard avenue; des plaines IL 60018
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 7843971
• MDR Text Key: 119151422
• Report Number: 1422160-2018-00003
• Device Sequence Number: 1
• Product Code: LPL
• 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,Followup
• Report Date: 09/11/2023

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 Catalogue Number: CBVUNK00090
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/12/2018; 09/12/2018; 08/16/2023
• Supplement Dates FDA Received: 10/05/2018; 10/10/2018; 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Removal/Correction Number: CORRECTION
• Patient Sequence Number: 1
• Patient Outcome(s): Other