MAUDE Adverse Event Report: ALCON GRIESHABER AG MS QUICK LOCK ADAPTOR; UNIT, PHACOFRAGMENTATION, ACCESSORY, PNEUMATIC HANDPIECE ADAPTOR

Catalog Number 712.00.01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Retinal Tear (2050)

Event Date 02/01/2023

Event Type  Injury  

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 Description

A customer reported via a clinical study that after a vitrectomy surgery a patient experienced retinal surface damage and hemorrhage.No further information expected as the details were received from a clinical study.

Manufacturer Narrative

No lot number was identified within the study and therefore within this complaint, which is why the associated manufacturing documentation could not be reviewed.All product and batch history records are quality reviewed prior to product release, ensuring that all products on the market fulfill the relevant requirements.Since the questionnaire retrospectively collects data, no sample is available to be provided to the responsible site for an in-depth investigation.Not enough information was provided to properly complete an investigation.The root cause of this complaint could not be identified.The exact root cause for the customer¿s reported event is unknown.Therefore, no specific action can be taken.The manufacturer internal reference number is: (b)(4).

• Brand Name: MS QUICK LOCK ADAPTOR
• Type of Device: UNIT, PHACOFRAGMENTATION, ACCESSORY, PNEUMATIC HANDPIECE ADAPTOR
• 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: 17207790
• MDR Text Key: 317905668
• Report Number: 3003398873-2023-00156
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K911808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 712.00.01
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 25+ GRIESHABER MAXGRIP REV DSP FORCEPS; 25+ REVOLUTION DSP ASYMMETRICAL FORCEPS; ADVANCED DISPOSABLE TIP ASYMMETRICAL FORCEPS; ADVANCED DISPOSABLE TIP CURVED SCISSORS; GRIESHABER ADVANCED DSP TIP FORCEPS; GRIESHABER ADVANCED DSP TIP SCISSORS; GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS; GRIESHABER REVOLUTION DSP FORCEPS; M5 QUICK LOCK ADAPTOR; REVOLUTION HANDLE; REVOLUTION HANDLE BLACK; SUTHERLAND HANDLE NEXT; SUTHERLAND HANDLE NG
• Patient Outcome(s): Other
• Patient Sex: Male