MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number 690880

Device Problem Complete Blockage (1094)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter telephone number: (b)(6).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing record could not be reviewed since the serial number was not provided.Trend analysis and the documentation/label review: there is not a recognizable adverse trend.The risks and mitigation's associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.The documentation/label review defines potential complications and adverse events associated with this type of surgery.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.Johnson & johnson surgical vision will continue to monitor the issues evaluated in this investigation.Conclusion: as a result of the investigation and based on limited information available, it cannot be determined if there is a product malfunction as no device failure was identified.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was blockage during surgery while using the ellips fx handpiece.The surgery completed successfully and patient recovered normally.No further information available.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 11821290
• MDR Text Key: 264965592
• Report Number: 3006695864-2021-07704
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K981116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 690880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1