MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. 2.5 MM TRIPLE STEP ANGLED FLARED PHACO NEEDLE. (DISPOSABLE); PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE

Catalog Number 8400.25A01

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

We have been informed that during phaco procedure, a piece came loose from the sleeve.The surgeon was able to remove the particle from the eye and completed surgery successful.No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

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 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

In regard to this complaint, two silicone phaco sleeves from a 2.5 mm triple step angled flared phaco needle set were received for investigation.It should be noted that the phaco needle set (part number 8400.25a01) was not part of the nordset pack with part number no91451185 that was indicated on the complaint form.Pertinent to the complaint description, the phaco sleeves were closely examined.The sleeves appeared to be completely intact and showed no other anomalies.Also, no particulate matter of any kind was detected.Since the 'piece' that allegedly 'came loose from the sleeve' was not received, an investigation as to its origin was not possible.As the lot number of the phaco needle set was unknown, device history record review could not be performed.A database search showed that no similar complaints have been reported.Based on the limited investigation, the reported failure could not be attributed to the returned product or its manufacture.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 the reported failure could not be attributed to the returned product or its manufacture, no remedial/corrective/preventive/field safety corrective action (fsca) was initiated.The analysis includes all complaints similar to (b)(4) (ph-sleeve-particles) and the combined sales figures of product that includes this phaco sleeve.Please note that the complaint numbers are up to date.The sales figures of 2023, however, only include data from january to may.Also, individual products may include more than one phaco sleeve (typically two).With these deviations and apart from the fact that no similar complaints have been reported, the table above clearly reflects a worst case scenario.

Event Description

We have been informed that during phaco procedure, a piece came loose from the sleeve.The surgeon was able to remove the particle from the eye and completed surgery successful.No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

In regard to this event, the product has been received.Investigation of the returned product did not reveal any anomalies.Further investigation to determine the root cause of the reported event is ongoing.This will include the review of the device history record.

Event Description

We have been informed that during phaco procedure, a piece came loose from the sleeve.The surgeon was able to remove the particle from the eye and completed surgery successful.No report that actual patient harm occurred or surgery was prolonged > 30 min.

• Brand Name: 2.5 MM TRIPLE STEP ANGLED FLARED PHACO NEEDLE. (DISPOSABLE)
• Type of Device: PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 16901252
• MDR Text Key: 314889570
• Report Number: 1222074-2023-00043
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2023

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: 8400.25A01
• Device Lot Number: 2022-1865
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/05/2023; 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1