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

Model Number	SCP680300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: COMPACT INTUITIV
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10782455
• Report Number: 3006695864-2020-00483
• Device Sequence Number: 19867177
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention