MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-10 for DYNJ60113 manufactured by Medline Industries Inc..
[129926058]
It was reported that at the beginning of the eye/cataract/iol/implant procedure, when the patient's eye was looked at under a microscope, it was discovered by the physician that there was a lint particulate floating on patient's lens. The lint particulate was reportedly possibly from the gauze located in the prep tray from the custom surgical pack (eye pack). It was added that the lint particulate reached the patient's eye/lens when medication from the medicine cup was administered to the patient's eye. Per report, the custom surgical pack's integrity was verified prior to use and the lint particulate was not identified in the medicine cup at that time. It was reported that irrigation was required to remove the lint particulate from the patient's eye/lens. The patient was under sedation at the time of the incident and there was no report of additional sedation medication required. Immediately in the post-operative phase, the patient was reportedly well. No impact to the patient, the procedure, or the total length of the procedure was reported. There was no serious injury or follow up care reported related to the event. Due to the reported incident and medical intervention, this medwatch is being filed. The sample is not available to be returned for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[129926059]
It was reported that irrigation was required to remove the lint particulate that was discovered floating on the patient's lens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00063 |
| MDR Report Key | 8147723 |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-12-10 |
| 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 | GAUZE FROM EYE PACK |
| Product Code | OJK |
| Date Received | 2018-12-10 |
| Catalog Number | DYNJ60113 |
| Lot Number | 18HDB581 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-12-10 |