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

Catalog Number	725.03
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that the connection part of an ophthalmic pneumatic handpiece would not allow for a forceps tip to screw in and connect prior to performing the scheduled combination cataract and vitrectomy surgery.There was no harm to any patient.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.10.The sample was received in opened original packaging including the cover foil.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The shutter was found to have scratches indicating the use of tools.Based on these marks, it can be assumed that the instrument was damaged during use.It is possible that the shutter was first turned in the wrong direction and therefore jammed.The correct handling of the device is described in the direction for use (dfu) of the instrument.This event is attributed to user handling.The device was damaged during handling.The correct handling of the instrument is described in the instruments dfu.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION PNEUMATIC HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 11727571
• Report Number: 3003398873-2021-00028
• Device Sequence Number: 14439612
• Product Code: HQC
• UDI-Device Identifier: 07612717071391
• UDI-Public: 07612717071391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063583
• 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,Followup
• Report Date (Section B): 06/29/2021

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 725.03
• Device Lot Number: F183254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 04/11/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1