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

Catalog Number	337.88
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A physician reported that during a combined cataract and vitrectomy for retinal detachment procedure an ophthalmic backflush tip came loose during the fluid/air exchange (fax) mode and remained in the eye.The surgery was completed and patient impact was not reported.Additional information has been requested but none received till date.
Additional Manufacturer Narrative
No lot number was identified with this complaint, therefore the manufacturing documentation was not reviewed.All product and batch history records are quality reviewed prior to product release.Sample was not received by the investigation site for evaluation.A sample was not received at the manufacturing site therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for the customers reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.The manufacturer internal reference number is: (b)(4).

• Brand Name: BACKFLUSH HANDLE DSP
• Common Device Name: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY
• 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 ; 8007579780
• MDR Report Key: 16326023
• Report Number: 3003398873-2023-00019
• Device Sequence Number: 12922940
• Product Code: HQE
• UDI-Device Identifier: 07612717071414
• UDI-Public: 07612717071414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K884043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 337.88
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown