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 590106AN manufactured by Johnson & Johnson Surgical Vision, Inc..
[185090659]
(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. Device evaluation: 1 pi was returned within its original packaging confirming the reported lot number of 60161103. A visual inspection of the returned device did not reveal any damage to the components and all parts were assembled correctly. Suction and dimensional testing was performed with all results within specification. The reported suction loss issue could not be confirmed. Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the pi lot# 60161103. All devices met material, assembly and performance specifications at the time of product released. Conclusion: based on the investigation results there is no indication of a product quality deficiency. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[185090660]
It was reported suction loss after the laser fired with less than 2 seconds left during the side cut on unknown eye. The surgeon visualized the side cut and it was temporally displaced approximately 1mm. Due to the displacement the flap, it was not lifted and the procedure was aborted. The patient came back and had photorefractive keratectomy (prk) on (b)(6) 2019, which was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00200 |
| MDR Report Key | 9878460 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-09-26 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-06 |
| 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 |
| Returned To Mfg | 2020-03-20 |
| Model Number | PI-RET |
| Catalog Number | 590106AN |
| Lot Number | 60161103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Required No Informationntervention | 2020-03-25 |