MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. AMO TAC VITRECTOMY HANDPIECE; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED

Model Number OM0201011D

Device Problems Labelling, Instructions for Use or Training Problem (1318); Appropriate Term/Code Not Available (3191)

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

It was reported that the account chinese people 's liberation army 96601 hospital purchased a phaco handpiece of unknown origin, which may have an unknown impact on surgical safety and phaco machines.It was also noted that the labeling on the handpiece packing box was inconsistent with that of the handpiece regular channel of j&j surgical vision, so the compatibility of the handpiece with phaco sovereign company machine was unknown and this led to a question of the surgical safety and normal operation of the instrument.No further information was provided.

Manufacturer Narrative

If implanted, give date: not applicable.If explanted, give date: not applicable.Telephone number: (b)(6).The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Correction: h6: medical device problem code from 1318 - labelling, instructions for use or training problem to 3191 - unspecified/other w/o patient involvement.Additional response: on further assessment, the product had a counterfeit label and there was no allegation against the jnj label.As such, it has been assessed as not reportable in the current state.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: AMO TAC VITRECTOMY HANDPIECE
• Type of Device: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15955351
• MDR Text Key: 308239985
• Report Number: 3012236936-2022-02909
• Device Sequence Number: 1
• Product Code: HKP
• UDI-Device Identifier: 0(01)(21)11442
• UDI-Public: (01)(21)11442
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K760684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OM0201011D
• Device Catalogue Number: OM0201011D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2006
• 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