MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-18 for INTRALASE FS2 20005D manufactured by Johnson & Johnson Surgical Vision, Inc..
[183980283]
Field service specialist (fss) visited the account and performed multiple z calibrations and simulated flaps in gel medium without any errors. Adjusted beam centering and video screen calibrations. Could not recreate error message. System meets specifications. A review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews for this equipment were performed. Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed. The trend review shows that there is not a recognizable adverse trend. The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation. All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183980284]
It was reported that while performing a flap on a male patient's right eye error message appeared with 9 seconds remaining. Surgeon decided to restart the procedure but aborted the case since same error appeared once again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00192 |
| MDR Report Key | 9850326 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-21 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRALASE FS2 |
| Generic Name | FEMTOSECOND LASER |
| Product Code | HNO |
| Date Received | 2020-03-18 |
| Model Number | 20005D |
| Catalog Number | 20005D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-03-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |