MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC UNK_PHACO TIP/NEEDLE; PHACO ACCESSORY

Model Number UNKNOWN

Device Problem Complete Blockage (1094)

Patient Problems Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4 - model #: the model # is unknown, as product lot number was not provided.Section d4 - catalogue#: the catalogue # is unknown, as product lot number was not provided.Section d4 - lot#: unknown/ not provided.Section d4 - expiration date: unknown as product lot number was not provided.Section d4 - udi #: unknown as product lot number was not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): the phaco tip was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.Device history record, complaint trending, and risk documentation for this device could be not be performed as the lot number was unknown.Section h4 - device manufacturing date: unknown / not provided.Section h6 -health effect - clinical code: 4581 - shallowing or collapsing of the anterior chamber : anterior chamber collapse.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a problem with the veritas phacoemulsification (phaco) machine.Surgeon reported that there was a problem with the vacuum pump.They had massive occlusion surges which caused anterior chamber (a/c) to collapse and there was no vacuum on the vitrectomy probe afterwards.The patient then had anterior chamber stability issues, a posterior capsule rupture and a vitrectomy was required.Through follow up it was reported that surgeon had started using a different size phaco tip on that day.No further information was provided.A separate report will be submitted for the veritas console.

• Brand Name: UNK_PHACO TIP/NEEDLE
• Type of Device: PHACO ACCESSORY
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18107951
• MDR Text Key: 327869263
• Report Number: 3012236936-2023-02837
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention