MAUDE Adverse Event Report: Alcon Grieshaber AG Backflush Handle DSP; Instrument, Vitreous Aspiration and Cutting, AC-Powered, Accessory

Catalog Number	337.84
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected information provided in sections b.2 and h.11.\ \ upon further review, it was identified that the backflush tip could not perform aspiration during calibration of the device.Based on this assessment, the aspiration issue is not considered a reportable malfunction because a serious injury had not occurred and it is not likely that a recurrence would result in serious injury.Therefore, the previously submitted event under manufacturer mfg.Report num: (b)(4) does not meet the criteria for mdr reporting as per applicable regulations.\ \ hence, no further reports will be submitted under mfg.Report num: (b)(4).\ \ the manufacturer internal reference number is:(b)(4).
Event or Problem Description
A physician reported that during test, an ophthalmic tip could not perform aspiration.Details of procedure was not reported.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
A sample is available that has not yet been received at 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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50881103
• Report Number: 3003398873-2026-00203
• Device Sequence Number: 10705247
• Product Code: HQE
• UDI-Device Identifier: 07612717071193
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K884043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 337.84
• Device Lot Number: 17X0NA
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 01/30/2026
• 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