MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2015-04-30 for ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE ES 5000 S manufactured by Bausch & Lomb, Inc..
[21937637]
It was reported that a patient developed cystoid macular edema after having a vitrectomy due to a retinal detachment on (b)(6) 2015. No other information available. Additional information has been requested, but no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
[22289570]
Investigation of this event is in progress. A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[39210258]
Despite multiple attempts to obtain additional info from the surgeon, no additional info has been received. The device was not returned to the manufacturer for evaluation. Therefore, a product evaluation could not be conducted. The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue. Based on the info available, the root cause of the reported event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2015-01169 |
| MDR Report Key | 4749056 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-04-30 |
| Date of Report | 2015-03-31 |
| Date Mfgr Received | 2015-03-31 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-05-06 |
| 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 | SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9193985698 |
| Manufacturer G1 | PHARMPUR |
| Manufacturer Street | MESSERSCHMITTRING 33 |
| Manufacturer City | KONIGSBRUNN 86343 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 86343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE |
| Generic Name | SILICONE OIL |
| Product Code | LWL |
| Date Received | 2015-04-30 |
| Model Number | ES 5000 S |
| Lot Number | 22414 |
| Device Expiration Date | 2016-07-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | ROCHESTER NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-30 |