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 2020-03-26 for SILVER PSCST30 manufactured by Johnson & Johnson Surgical Vision, Inc..
[185224768]
Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. Expiration date: unknown, as the lot number was not provided. Lot number: unknown, information not provided. Udi number: unknown, as the lot number was not provided. Catalog number: unknown, as the lot number was not provided. If implanted; give date: n/a (not applicable). The cartridge is not an implantable device. If explanted; give date: n/a (not applicable). The cartridge is not an implantable device. An attempt has been made to obtain missing information; however, no definitive response has been received. The reported lens damage is being submitted in a vmsr filing. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[185224769]
It was reported that a z9002 intraocular lens was loaded into the silver shooter when the doctor tried to insert it in the patient? S eye. The lens did not disengage from the cartridge. The doctor handed the iol back to the scrub tech and asked that she reloads the lens. But when the scrub tech was attempting to reload the iol, she noticed markings on the lens in the peripheral area. It was learned that there was indeed patient contact with the lens. The lens was partially delivered, then the lens got stuck in cartridge. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00292 |
| MDR Report Key | 9887154 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-26 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-27 |
| 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 | ROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILVER |
| Generic Name | SURGICAL ADJUNCTS |
| Product Code | KYB |
| Date Received | 2020-03-26 |
| Model Number | PSCST30 |
| Catalog Number | PSCST30 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-26 |