MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Model Number 8000.COM05

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Clouding, Central Corneal (2228)

Event Type  Injury  

Manufacturer Narrative

Investigation is started.(b)(4).

Event Description

Serious post-operative result with cloudy corneas.

Manufacturer Narrative

A complaint concerning an eva system was filed.It was reported that after a cataract surgery, 4 patients experienced a loss of transparency of the cornea (so called cloudy cornea).Our representative contacted a surgeon in charge in order to check up on the patients' condition.It turned out that all 4 patients were in a good state next day after the operation and no further complications were observed.In addition, the surgeon explained that he did not have much experience with the machine, as he used it for the first time.Dorc requested log files of the eva system and instruments used during the surgeries to be sent for investigation.Unfortunately, given the delay between the alleged incident and reporting to dorc, only incomplete log files could be recovered and all related consumables were discarded.An analysis of the available log files did not revealed any abnormalities in the functioning of the machine.It was also noted during the investigation that the user in this case was using the machine for the first time.Based on the results of the performed investigation and information provided by the customer a root cause could not be clearly determined.Potential cause of a cloudy cornea related to an eva system could be too high irrigation pressure or patient eye level (pel) setting used during surgery.However, none of these issues was reflected in the log files.Incorrect placement of the bottle with balanced salt solution could also result in too high pressure, but this eventuality was not confirmed with the surgeon.The surgeon who reported these issues confirms that no subsequent issues of this nature have been noted, and the unit continues to perform as expected.In this case dorc consider that this incident by closed with nonconclusive findings, and dorc will continue to monitor the installed base of eva.- attachment: [mir 2019-000653 final report signed.Pdf].

Event Description

Serious post-operative result with cloudy corneas.

Event Description

Serious post-operative result with cloudy corneas.

Manufacturer Narrative

Log files of the eva system which had the alleged problems were received by d.O.R.C.An investigation of these log files will be initiated by r&d department as soon as more information (i.E.Exact time of event to enable interrogation of the logfiles) from the hospital is provided.- attachment: [mir 2019-000653 follow up report signed.Pdf].

• Brand Name: EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC CONNECTOR)
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, 3214 VN; NL 3214 VN
• MDR Report Key: 8856679
• MDR Text Key: 153150338
• Report Number: 1222074-2019-00020
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8000.COM05
• Patient Sequence Number: 1