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

Model Number	SCP680300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012236936-2022-02534
• Device Sequence Number: 20651067
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NGP0023
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown