MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC COMPACT INTUITIV; UNIT, PHACOFRAGMENTATION

Model Number SCP680300

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Capsular Bag Tear (2639)

Event Date 09/09/2022

Event Type  Injury  

Event Description

It was reported that there was a capsule rupture and a vitrectomy was required.The surgeon tried to use a-vit (anterior vitrector) but couldn t use it because of error 340 (vitrectomy pressure leak) which occurred in vitrectomy prime mode.No other patient injury or surgical intervention was reported.Additional information was received, and it was learnt that the procedure was completed without using the vitrectomy cutter.Day 1 postoperatively, surgeon checked the patient's eye and confirmed there was no issue.No further information provided.

Manufacturer Narrative

Additional narrative information: reported phone number: (b)(6).Device evaluation: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information additional information was received that there was a sclera-corneal incision of 2.75mm.The patient outcome was well.The technical support team informed that the alleged machine was inspected by field service engineer, and the issue was not reproduced.Field service engineer (fse) did nothing on the machine.The machine was returned to the customer.Fse also reported that according to sales representative the issue had possibly caused by the fact that customer did not completely close the vitrectomy cutter when attaching to the machine.Section h6: in the initial mdr code was 3221 however based on investigation the code has been updated to 213 - no device problem found.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: COMPACT INTUITIV
• Type of Device: UNIT, PHACOFRAGMENTATION
• 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: 15577340
• MDR Text Key: 301509280
• Report Number: 3012236936-2022-02534
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133115
• 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,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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
• Treatment: NGP0023
• Patient Outcome(s): Required Intervention