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	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that before surgery the tip of handpiece was not affixed and the part put together came off.The surgery was performed and completed after replacing the product with another one.There was no patient harm associated with this reported event.
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).
Additional Manufacturer Narrative
Sample was received for investigation.The received instrument showed a disconnected fixation ring.This ring is fixed with a left-turning instrument below the bayonet closure.The received hand piece was connected to the console and all function were proven.No abnormality could be determined.The fixation ring was replaced on the thread and worked well again.No abnormality could be determined.Based on the feedback of the customer the not affixed tip seems to be the fixation ring.The production process includes a 100% visual inspection and finally a sample-based qc-inspection at the end of the production process.Therefore, it is unlikely that the pneumatic hand piece left production with a non-affixed fixation ring.The packaging and transportation validation for the pneumatic hand piece has been successfully performed.Therefore, it is unlikely that the fixation ring disconnected during transportation.It can be confirmed that the fixation ring was disconnected form the pneumatic hand piece.The cause for this issue cannot be identified anymore.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
• 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: 12861716
• Report Number: 3003398873-2021-00089
• Device Sequence Number: 4609025
• 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): 02/10/2022

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 725.03
• Device Lot Number: F189422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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