MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2.2 MM DISPOSABLE FLARED NEEDLE PHACO SET. (FOR INCISION SIZE 2.2-2.4 MM); PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE

Catalog Number 8400.22F03

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The incident is being investigated to determine if the fragment of plastic could have come from the instrument in use at the time.

Event Description

During phacoemulsification the surgeon identified a blue plastic piece in the anterior chamber.

Event Description

During phacoemulsification the surgeon identified a blue plastic piece in the anterior chamber.

Manufacturer Narrative

With regard to this complaint, a pouch with a blue particle was received.Neither the involved phaco needle nor any other product was returned for investigation.Based on its color and texture, microscopic examination revealed that the light blue particle (2.13 mm x 0.54 mm) is determined to be plastic.Therefore, the particle could not have originated form the phaco handpiece, the phaco needle or the phaco sleeve.The color and texture of the particle were compared to blue plastic dorc product that is used during cataract surgery.Colors of the eva cartridge, the infusion tubing connector and the dorc 2.2 mm slit knife did not match the color of the particle and could not have been the source.In fact there was only one product that appears to match with the color of the particle and that was a 2.2 mm slit knife from a competitor.As we have not received information regarding the use of competitor product during the operation, the latter could not be confirmed.Review of the device history records related to the reported lots revealed no deviations.

• Brand Name: 2.2 MM DISPOSABLE FLARED NEEDLE PHACO SET. (FOR INCISION SIZE 2.2-2.4 MM)
• Type of Device: PHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 9632212
• MDR Text Key: 182016458
• Report Number: 1222074-2020-00008
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8400.22F03
• Device Lot Number: 2000407823
• Patient Sequence Number: 1