MAUDE Adverse Event Report: ALCON GRIESHABER AG CONSTELLATION PNEUMATIC HANDPIECE; UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE

Catalog Number 725.03

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation.As the affected lot number is not known, the device history record could not be reviewed.A 100% final inspection is performed for this product.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.The sample is not available for investigation therefore, damage cannot be confirmed or rather a root cause cannot be identified.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that the tip of an ophthalmic pneumatic handpiece came off of the device after a vitrectomy surgery, there was no harm to the patient.

• Brand Name: CONSTELLATION PNEUMATIC HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10123899
• MDR Text Key: 194759566
• Report Number: 3003398873-2020-00044
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2020

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 Catalogue Number: 725.03
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1