MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. COMPACT INTUITIV CONSOLE

Model Number SCP680300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).The system was evaluated by a field service engineer (fse).The field service found no issues with the unit.A field service checklist was performed.The unit complied with all factory settings.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.

Event Description

It was reported a capsule tear occurred while the surgeon was performing epi nucleus and, due to the sudden stop of the system, a posterior capsular rupture (pcr) occurred.The system was restarted, and the surgeon proceeded with the surgery.The pcr enlarged and the surgeon decided to switch from a multifocal iol to a sensar 3-piece lens.The patient was aphakic at the end of the surgery for 1 hour 30 minutes.An unplanned vitrectomy was performed.The patient's outcome is unknown.

Manufacturer Narrative

Correction g4: in the initial mdr, the date aware was missing.The correct date for g4 is 10/13/2020.

• Brand Name: COMPACT INTUITIV CONSOLE
• Type of Device: COMPACT INTUITIV
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10782455
• MDR Text Key: 214520540
• Report Number: 3006695864-2020-00483
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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
• Device Operator: Health Professional
• Device Model Number: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention