MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-11 for SOLO IA TIP, STRAIGHT, .3MM OPO1A20STR manufactured by Johnson & Johnson Surgical Vision, Inc..
[183822494]
Unique identifier (udi#) is not provided at this time. Telephone: (b)(6). Manufacturer date is not provided at this time. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183822495]
During a cataract extraction procedure, the surgery center reported a capsular tear in the patient? S operative eye requiring a vitrectomy procedure when using the irrigation and aspiration (i/a) tip. A description of the event indicated the capsule ruptured during the vacuum segment and it was alleged that the tip of i/a handpiece was deformed. The surgery center reported the tip had been used multiple times prior to event without incident, however, it is unknown the exact number of usages as there was no record kept. Although there was a 20-minute delay, the procedure was completed. The patient outcome is well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00171 |
| MDR Report Key | 9820252 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-02 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-11 |
| 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 | SOLO IA TIP, STRAIGHT, .3MM |
| Generic Name | PHACO ACCESSORY |
| Product Code | HQC |
| Date Received | 2020-03-11 |
| Model Number | OPO1A20STR |
| Lot Number | 086865 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |