MAUDE Adverse Event Report: ALCON LABORATORIES, INC. VITRECTOMY 25G VALVED CUSTOM SURGICAL PACK; OPHTHALMIC TROCAR CANNULA

Catalog Number AS1666704

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

Event Description

The pack was labeled as 25-gauge; however, when it was opened by the surgical technician, she noticed that it had 23-gauge instrumentation inside of the pack with the wrong products.The pack was taken out of circulation and was disposed of.Packs of the same lot were checked and replaced.Manufacturer response for custom pack, vitrectomy, 25 gauge valved pack (per site reporter).All affected packs have been replaced and an investigation has been opened.

• Brand Name: VITRECTOMY 25G VALVED CUSTOM SURGICAL PACK
• Type of Device: OPHTHALMIC TROCAR CANNULA
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 9224613
• MDR Text Key: 163363356
• Report Number: 9224613
• Device Sequence Number: 1
• Product Code: NGY
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AS1666704
• Device Lot Number: 2296562H
• 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: 09/18/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1