MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for DYNJ53299A manufactured by Medline Industries Inc..
[104527159]
It was reported that an unknown number of patients undergoing cataract extraction had blue fibers/particulates falling in their eyes which were retrieved using instruments by the surgeon. Reportedly, the particulates were microscopic and were not visible during initial product inspection prior to use. The reporting facility believed the blue fibers/particulates were possibly from the table cover and transferred into the patients' eyes through the instruments that were used for the procedure. It was reported that the patients were treated with steroids for corneal edema and inflammation but it wasn't sure if this was due to the blue fibers/particulates. Monitored anesthesia care was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. No sample was available to be returned for evaluation. The complaint cannot be confirmed. A root cause cannot be identified at this time. Due to the reported incident and in an abundance of caution, this medwatch is being filed. No additional information was provided. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[104527160]
It was reported that an unknown number of patients undergoing cataract extraction had blue fibers/particulates falling in their eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00019 |
| MDR Report Key | 7400268 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-04-05 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | EYE PACK |
| Product Code | OJK |
| Date Received | 2018-04-05 |
| Catalog Number | DYNJ53299A |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-05 |