MAUDE Adverse Event Report: CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. PRECISION1 SPHERICAL; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92092150

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

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

Event Description

As initially reported by non-healthcare professional stating that after wearing contact lenses several patients experiencing corneal ulcers, no further additional information regarding the product and consumer identifiers is known at this time, the current symptom resolution is unknown at the time of this report.Additional information has been requested but not yet received.

• Brand Name: PRECISION1 SPHERICAL
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.; 133 tuas south avenue 3; tuas 63755 0; SN 637550
• Manufacturer (Section G): CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.; 133 tuas south avenue 3; tuas 63755 0; SN 637550
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18960717
• MDR Text Key: 338377186
• Report Number: 3003657720-2024-00003
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBV92092150
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other