MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2.2 MM DISPOSABLE PHACO SET WITH 45° STRAIGHT FLARED NEEDLE; PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE

Catalog Number 8445.22SF1

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that prior to use, foreign material was noticed inside the instrument.Therefore, the product was not used.No patient harm occurred.

Manufacturer Narrative

The complaint article was received for investigation.Visual inspection confirmed the foreign material as described in the reported event.As the origin of the material could not be clearly determined within d.O.R.C., the product will be analyzed in a external laboratory.As soon as results are available, the root cause investigation will be continued.

Event Description

We were informed that prior to use, foreign material was noticed inside the instrument.Therefore, the product was not used.No patient harm occurred.

Event Description

We were informed that prior to use, foreign material was noticed inside the instrument.Therefore, the product was not used.No patient harm occurred.

Manufacturer Narrative

In regard to this complaint, one phaco sleeve from a disposable phaco set was received for investigation.As received, the phaco sleeve was not received in its original packing.Visual inspection confirmed the presence of a yellow foreign material in on the phaco sleeve.Since its origin could not be determined within dorc, the material was sent to sgs laboratories in belgium for forensic analysis.The results of the forensic investigation revealed that the material found in unopened pouch consisted of a combination of different components on one side there is a transparent polymer layer based on pet (polyethylene terephthalate) and on the other side there is the combination of a polyacrylate glue and opaque flakes consisting of pet & titanium oxide.Unfortunately, also after forensic investigation, the origin of the material is still unknown.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported on this specific lot previously.Since the phaco sleeve was not in the original packaging, we cannot exclude the possibility that the foreign material was introduced after the product left the controls of dorc.Based on the performed investigation, a manufacturer related failure could not be confirmed.Please note that the assembly of the product is executed in a class 7 clean room environment to ensure minimum contamination and that these products are subject to 100% visual inspection prior to being released for distribution.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.All products in the product group "phaco needles (single-use)" are included in the analysis.

• Brand Name: 2.2 MM DISPOSABLE PHACO SET WITH 45° STRAIGHT FLARED NEEDLE
• Type of Device: PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE
• 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: danielle sleegers ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 14353082
• MDR Text Key: 291359807
• Report Number: 1222074-2022-00040
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8445.22SF1
• Device Lot Number: 2000428589
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1