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 2020-03-31 for PLATINUM 1 SERIES 1MTEC30 manufactured by Johnson & Johnson Surgical Vision, Inc..
[185732983]
Age/date of birth: unknown/not provided. Sex/gender: unknown/not provided. 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. 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. (b)(6). Device manufacture date: unknown as lot number was not provided. All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[185732984]
It was reported that after the intraocular lens (iol) was implanted in the eye, the surgeon found tiny fragment which she pinched it out. It was indicated that the patient did not react / show any problem. The surgeon experienced the same situation twice in different hospitals with two different lenses in two weeks. The surgeon thinks the fragment is from the cartridge and not the iol as they checked the lens before loading it into the cartridge and the lens was clear from fragment. No additional information was provided. This report pertains to the first reported incident. A separate report will be submitted for the second incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00302 |
| MDR Report Key | 9901999 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| 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 | 2020-03-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |