MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-28 for PLATINUM 1 SERIES 1MTEC30 manufactured by Johnson & Johnson Surgical Vision, Inc..
[181373666]
Date of event: unknown, not provided. Lot number: unknown, information not provided. Unique device identifier (udi #): complete udi# is unknown, as lot number was not provided. Expiration date: unknown, as lot number was not provided. Device manufacture date: unknown as 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; therefore, not explanted. Device evaluation: the product was not returned to the manufacturing site; therefore, the complaint issue reported was not verified. Manufacturing records review: manufacturing record evaluation could not be performed since lot number is unknown. Historical data analysis: the complaint history could not be performed since lot number is unknown. Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[181373667]
It was reported that a zcb00 intraocular lens (iol) was stuck in the platinum (1mtec30) cartridge and partially inserted into the patient's right (od) eye. The customer noted that the cartridge broke and cracked upon ejection of the lens into the eye. There was no surgical intervention required and no harm to the patient. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00193 |
| MDR Report Key | 9767846 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-28 |
| 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 | PLATINUM 1 SERIES |
| Generic Name | SURGICAL ADJUNCTS |
| Product Code | KYB |
| Date Received | 2020-02-28 |
| Model Number | 1MTEC30 |
| Catalog Number | 1MTEC30 |
| 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 | 2020-02-28 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |