MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for IFS J20007K manufactured by Johnson & Johnson Surgical Vision, Inc..
[185089315]
Age/date of birth: unknown/ not provided. (b)(6). (b)(4). Device evaluation the femtosecond laser machine was examined and tested at the customer location by an jjsv field service specialist (fss). The fss checked gel at surgery settings. 80 percent melt. Easy lift. The fss performed a field service checklist. The system was verified for all modes of operations. The system met jjsv specifications. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specification. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[185089316]
It was reported that a laser vision correction patient experienced a tear on the patient? S right operative eye on treatment date (b)(6) 2020. A description of the event is the surgeon noted a small tear on the flap close to the flap hinge after he lifted the flap. In addition, a small opaque bubble layer observed as well. The patient was treated successfully on both eyes. At a routine post-op exam, eye drops and bandage contact lens (bcl) were prescribed. At a one day post op exam, both flaps were clear and had good flap edges. Ucva at one day post op. Re 6/6 le 6/7. 5. Ucva at one week post op. Ucva re 6/5 le 6/5.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00212 |
| MDR Report Key | 9882579 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-29 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-26 |
| 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 | IFS |
| Generic Name | FEMTOSECOND LASER |
| Product Code | HNO |
| Date Received | 2020-03-26 |
| Model Number | J20007K |
| 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 | 2020-03-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |