MAUDE Adverse Event Report: ALCON GRIESHABER AG BACKFLUSH HANDLE DSP; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY

Catalog Number 337.88

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

No sample has been received by manufacturing for evaluation.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 physician reported that the soft tip of an ophthalmic backflush device detached into and was retained inside of a patient's eye during surgery which was noted upon examination after the surgery.A subsequent, additional procedure was performed in order to remove the detached tip from the patient's eye.There was no further harm to the patient.Additional information has been requested.

Manufacturer Narrative

No sample was received at manufacturing as it was confirmed to have been discarded.As the affected lot is not known, the device history record could not be reviewed, but a 100% final inspection is performed for this product.It was determined that 12 comparable complaints in japan were confirmed in 2019.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.The sample was discarded.The sample is not available for investigation because it was discarded therefore, damage cannot be confirmed or rather a root cause cannot be identified.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received further clarified that the detached soft tip was successfully removed from the patient's left eye on (b)(6) 2019.The patient's condition was reported as good and recovered.

• Brand Name: BACKFLUSH HANDLE DSP
• Type of Device: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 9181933
• MDR Text Key: 164866556
• Report Number: 3003398873-2019-00078
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• PMA/PMN Number: K884043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 337.88
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR