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 2020-03-05 for INTRALASE PI-RET manufactured by Johnson & Johnson Surgical Vision, Inc..
[182566025]
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
[182566026]
During the raster pattern we lost suction right before the side cut. Doctor released pedal. Surgeon followed the suction break protocol. Re-applanated took pocket off. Centered the laser over raster pattern and completed flap. While the doctor was lifting he was having trouble getting the flap up and looked like he might be on the wrong plane. He decided to stop lifting the flap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00161 |
| MDR Report Key | 9796150 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-12-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Model Number | PI-RET |
| Catalog Number | PI-RET |
| 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 | 2020-03-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |