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 2020-03-13 for INTRALASE FS2 20005D manufactured by Johnson & Johnson Surgical Vision, Inc..
[183374126]
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.
Patient Sequence No: 1, Text Type: N, H10
[183374127]
The surgeon reported bilateral diffuse lamellar keratitis (dlk) post lasik procedure. Steroid drops were increased. No loss of best corrected visual acuity (bcva) was reported. It was reported that the procedure went well without issue. The only change was a new instrument was used to lift the flap. The dlk was worse in the right eye, which was treated first.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00178 |
| MDR Report Key | 9831007 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Model Number | 20005D |
| Catalog Number | 20005D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |