MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ALCON, ENGAUGE; LASER, OPHTHALMIC

Model Number 8065751593

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

Did not fit smoothly into the inlet it was supposed to go in.When they felt they had to force it to make it go in, they stopped and opened new product.Manufacturer response for probe light laser 25g, (brand not provided) (per site reporter).Issued rga# (b)(4), sending call tag, will issue credit for product.

• Brand Name: ALCON, ENGAUGE
• Type of Device: LASER, OPHTHALMIC
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 15484590
• MDR Text Key: 300569533
• Report Number: 15484590
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8065751593
• Device Catalogue Number: 8065751593
• Device Lot Number: 31442078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1