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

Catalog Number	725.03
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
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 an ophthalmic forceps tip did not open and close during a surgery.The surgery was completed without patient impact.
Additional Manufacturer Narrative
The sample was received with inner blister, outer blister and without cover foil.The sample shows no macroscopic signs of damage.The sample was functionally tested with the op laser.A dsp forceps was used as an essay.The surgical laser recognized the device.During the investigation, the sample was tested with the foot switch and also with different programs.The device was fully functional.The customer's complaint was not confirmed.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications; it is not likely that a product malfunction could have contributed to the reported event.No action was taken as the returned sample met specifications for tests performed in relation to the reported event.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.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
• 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: 15403014
• Report Number: 3003398873-2022-00077
• Device Sequence Number: 6123587
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 725.03
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown