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 20003D manufactured by Johnson & Johnson Surgical Vision, Inc..
[183373598]
(b)(4). A record review was performed. A product deficiency review was performed and there is no product deficiency identified. The risk management files and trending were reviewed. There is not a recognizable adverse trend. The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183373599]
It was reported that a laser vision correction patient had surgery on (b)(6) 2020 and presented on (b)(6) 2020 with small striae in superior nasal area of the left eye with small gutter. The patient reported foreign body sensation and light sensitivity. A bandage contact lens was placed. It was stated that the patient had no loss of best corrected visual acuity (bcva) and symptoms did not interfere with daily activities. Bcva from (b)(6) 2020: right eye pre-op 20/15 -5. 00 x. 00 x 90; left eye pre-op 20/15 -4. 50 x -. 50 x 175.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00179 |
| MDR Report Key | 9831621 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-19 |
| 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 | 20003D |
| 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 | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |