MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE; PHACOEMULSIFICATION SYSTEM HANDPIECE

Catalog Number 3002.M

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

We have been informed that during procedure, after successful priming, in phase 'quadrant removal' there was no phaco energy and the ultrasound did not break the nucleus.The user exited the program, turned off the machine and tested the handpiece again, but could not pass priming.Another handpiece was used and the procedure was finished without complication.Due to the reported event surgery was prolonged > 30 minutes.No report that actual patient harm occurred.

Manufacturer Narrative

The complaint is under investigation in case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of the this report, in case the investigations that alter the device should be halted until approval of the nca , as per article 89 of eu-mdr.

Manufacturer Narrative

The complaint is under investigation.Edek 17-01-2023: r&d has been requested to perform log file analysis.No corrective or preventive actions can be implemented until the investigation has been completed.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of the this report, in case the investigations that alter the device should be halted until approval of the nca , as per article 89 of eu-mdr.

Event Description

We have been informed that during procedure, after successful priming, in phase 'quadrant removal' there was no phaco energy and the ultrasound did not break the nucleus.The user exited the program, turned off the machine and tested the handpiece again, but could not pass priming.Another handpiece was used and the procedure was finished without complication.Due to the reported event surgery was prolonged 30 minutes.No report that actual patient harm occurred.

Manufacturer Narrative

According to the information in the complaint record, the involved phaco handpiece was received on 15feb23.Investigation is now pending.Device investigation is pending.As investigations on the actual product may alter the device, we request to inform us within 7 days after submission of the this report, in case the investigations that alter the device should be halted until approval of the nca , as per article 89 of eu-mdr.

Event Description

We have been informed that during procedure, after successful priming, in phase 'quadrant removal' there was no phaco energy and the ultrasound did not break the nucleus.The user exited the program, turned off the machine and tested the handpiece again, but could not pass priming.Another handpiece was used and the procedure was finished without complication.Due to the reported event surgery was prolonged > 30 minutes.No report that actual patient harm occurred.

Manufacturer Narrative

According to our information, the involved phaco handpiece was returned to dorc for investigation; however, due to unknown reasons, the product could not in fact be located.Without the involved product, no visual inspection or functional testing could be performed to confirm any product failure and to determine a cause for the performance issues experienced by the user.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.Since neither the reported product failure, nor its (possible) cause could be confirmed, a remedial action/corrective action/preventive action/field safety corrective action (fsca) is deemed not necessary.The analysis includes all complaints with failure mode ph-performance-prolonged (zero) and the 3002.M phaco handpieces that were sold in the listed time frames.Since phaco handpieces are reusable devices, using the sales figures leads to the worst case scenario in terms of complaint rates.Unfortunately, since we have limited information on the use of any handpiece in the field, the amount of phaco procedures per year can only be guessed.Please note that performance issues are reported to dorc from time to time.As this type of failure will not lead to serious deterioration in the state of health of a user or patient, the cases are usually not considered reportable events.The reason for reporting this particular performance issue is that it had caused prolonged surgery.Currently, we're not aware of any other prolonged surgeries due to performance issues.

Event Description

We have been informed that during procedure, after successful priming, in phase 'quadrant removal' there was no phaco energy and the ultrasound did not break the nucleus.The user exited the program, turned off the machine and tested the handpiece again, but could not pass priming.Another handpiece was used and the procedure was finished without complication.Due to the reported event surgery was prolonged > 30 minutes.No report that actual patient harm occurred.

• Brand Name: FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE
• Type of Device: PHACOEMULSIFICATION SYSTEM HANDPIECE
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 15860713
• MDR Text Key: 307921471
• Report Number: 1222074-2022-00086
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 3002.M
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2023; 02/27/2023; 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1