MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC IFS; FEMTOSECOND LASER

Model Number J20007K

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Field service specialist visited the account and found mechanical problem with galvo block.Galvo block was replaced.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 that laser system stopped a bit after the procedure started.Procedure was not completed.Surgeon asked the patient to change refractive treatment to photorefractive keratectomy and patient chose not to proceed.It was reported there was no consequence to the patient as only the pocket was performed and it was from pupil area.Pre-op va (visual acuity): 1.0 / 1.0; post-op va: 1.0 / 1.0.

• Brand Name: IFS
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 7449825
• MDR Text Key: 106136843
• Report Number: 3006695864-2018-00879
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474573475
• UDI-Public: (01)05050474573475
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: J20007K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR