MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-18 for EYE PACK STANDARD-LF DYNJS0120 manufactured by Medline Industries, Inc..
[1805967]
A pt required a surgical procedure to remove blue filaments from the eye following a cataract procedure.
Patient Sequence No: 1, Text Type: D, B5
[8902674]
The surgeon was doing a cataract procedure and reported seeing blue smooth filaments in the pt's eye. These were seen when using the microscopic equipment that is used during the procedure. The pt returned for a second procedure to remove blue particles after inflammation developed. The pt was reported to be doing well and no further complications were reported. The source of the filaments is not known. No sample was retained for eval and the lot number is not known. The surgeon theorized that the source of the filaments was the bowl. Randomly pulled samples of the blue plastic components in the pack including the bowl and 2-compartment tray. They were visually inspected. They were then inspected using an eye loop with no defects or abnormalities detected. A root cause has not been determined. However, due to the reported incident and need for surgical intervention, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2010-00069 |
| MDR Report Key | 1908339 |
| Report Source | 05,06 |
| Date Received | 2010-11-18 |
| Date of Report | 2010-11-09 |
| Date of Event | 2010-09-23 |
| Date Facility Aware | 2010-10-11 |
| Date Mfgr Received | 2010-10-11 |
| Date Added to Maude | 2010-11-30 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYE PACK STANDARD-LF |
| Generic Name | NONE |
| Product Code | OJK |
| Date Received | 2010-11-18 |
| Model Number | DYNJS0120 |
| Lot Number | UNK MEX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-18 |