MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INTREPID TRANSFORMER; UNIT, PHACOFRAGMENTATION

Catalog Number 8065752885

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

A customer reported that during a procedure, the secondary tip broke off while inside a patient's eye.The tip was removed during the initial procedure.The case was completed without patient harm.

Manufacturer Narrative

An opened disposable i/a handpiece was returned for evaluation.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The disposable i/a handpiece was visually inspected and deemed nonconforming.Aspiration handpiece (back side) polymer i/a tip was not attached to the cannula.Signs of use.The complaint evaluation confirms the polymer tip broke from the cannula.How and when the polymer tip broke cannot be determined from this evaluation.The most likely cause of a broken polymer tip is from improper handling of the product.All disposable i/a handpieces are 100% visually inspected by trained operators during the manufacturing process.Any nonconformance, such as the broken polymer i/a tip exhibited on the returned opened sample, is removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.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).

• Brand Name: INTREPID TRANSFORMER
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 10289575
• MDR Text Key: 200485075
• Report Number: 2523835-2020-00141
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 8065752885
• Device Lot Number: 13E161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 08/24/2020; 10/02/2020
• Supplement Dates FDA Received: 09/03/2020; 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR