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 2020-03-19 for INTRALASE 590106AN manufactured by Johnson & Johnson Surgical Vision, Inc..
[184206706]
The patient interface (pi) suction ring may lose suction during a procedure. Label copy states corneal fixation vacuum loss can occur. There are several factors that may contribute to suction issues such as doctor? S technique in applying the suction ring to the cornea, doctor? S technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patient? S cornea and the suction ring. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[184206707]
It was reported that patient presented for bilateral lasik on (b)(6) 2020. The left eye was treated first without incident. Suction was lost during the raster pattern near the visual axis on the right eye, procedure was aborted at that time. Lasik or right eye was reattempted on (b)(6) 2020 with adjustments made to the flap diameter and depth per protocol with no visible adverse event during the raster pattern or side cut. Upon attempting to lift the flap on the right eye, the flap was entered at the edge of the superior flap hinge and undermined on each side with difficulty lifting the inferior flap at the side cut indicating the possibility of more that one plane of dissection. Treatment with the visx was not performed at this time and the flap was repositioned and bandage contact lens was placed over cornea and pressure patch placed over closed lids. Due to resulting corneal edema, the secondary plane of dissection was not satisfactorily repositioned and patient will return to surgery center on (b)(6)2020 for further treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00193 |
| MDR Report Key | 9858021 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-17 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Generic Name | FEMTOSECOND LASER |
| Product Code | HNO |
| Date Received | 2020-03-19 |
| Model Number | 590106AN |
| Catalog Number | 590106AN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |