MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. TOTALVIEW CHANDELIER FOR ECKARDT CANNULA SYSTEM.(23 GAUGE / 0.6 MM); OPHTHALMIC FIBREOPTIC-LIGHT INSTRUMENT, SINGLE-USE

Catalog Number 3269.EB06

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/25/2023

Event Type  malfunction  

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 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 the customer received three items of ref (b)(4) which are non sterile because the folio packaging is untight and not properly sealed.Products have therefor not been used.No patient involvement.

Manufacturer Narrative

In regard to this complaint, one box, including three light fibers, was received.Examination of the returned product showed that the peel pouches that held the light fibers were not sealed.Based on the concise investigation, it was clear that the product was not packaged in accordance with the device master record.According to the work instruction, the pouches should be sealed in accordance with sop 003.The purpose of sop 003 is to describe and define the process of packaging medical devices in laminate packaging in order to guarantee the sterility of a product for a longer period of time after a sterilization step.Despite visual inspection, the non-sealed pouches were not detected prior to them being placed in the secondary packaging.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.Instructions on packaging and visual inspection were found to be clear; however an awareness training to emphasize the importance of maintaining the sterility of the product is to be provided to the cleanroom and packaging personnel.The analysis includes all complaints with failure mode as evaluated li-packaging-seal and the sales figures of light fibers.Light fibers that were distributed within packs were excluded, since those are placed in blister packs together with other product rather than in peel pouches.

Event Description

We have been informed that the customer received three items of ref (b)(6) which are non sterile because the folio packaging is untight and not properly sealed.Products have therefor not been used.No patient involvement.

• Brand Name: TOTALVIEW CHANDELIER FOR ECKARDT CANNULA SYSTEM.(23 GAUGE / 0.6 MM)
• Type of Device: OPHTHALMIC FIBREOPTIC-LIGHT INSTRUMENT, 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: 18046361
• MDR Text Key: 327033347
• Report Number: 1222074-2023-00078
• Device Sequence Number: 1
• Product Code: MPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3269.EB06
• Device Lot Number: 7284-*-*-1
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1