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 2020-03-25 for INTRALASE PI-RET manufactured by Johnson & Johnson Surgical Vision, Inc..
[185091104]
(b)(4). 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. A manufacturer record review related to the device including device history record will be performed. Upon completion of this review, if there is any further relevant information obtained that changes the facts and/or conclusion, 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
[185091105]
The surgery center reported suction loss while laser firing. The surgery center realigned the same patient interface cone and tried again but lost suction a second time. The procedure was aborted. The patient will be brought at a later date to complete the procedure and convert to a photorefractive keratectomy (prk) after the eye is healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00201 |
| MDR Report Key | 9878626 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-25 |
| 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 | PATIENT INTERFACE |
| Product Code | HNO |
| Date Received | 2020-03-25 |
| Model Number | PI-RET |
| Lot Number | 60207828 |
| 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 | 2020-03-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |