MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for DYNJ34123G manufactured by Medline Industries Inc..
[145773113]
It was reported that on post-operative day one, lint was discovered on the anterior chamber of patient's left eye, which underwent phacoemulsification with intraocular lens implantation. Reportedly, this lint was from the linting back table cover (taken from cataract pack). It was added that potentially the lint reached the operative site through contact with an instrument/hand piece. It was denied that patient experienced any symptom and the incident was noted during a routine post-surgical follow-up. An anterior chamber wash out, performed under sedation, was required to successfully retrieve the lint from the patient's left eye. Per report, there is no known impact to the patient or to the procedure performed and there is good surgical outcome at this time. Due to the reported incident and required medical intervention to retrieve the lint, this medwatch is being filed. The sample is not available to be returned for evaluation. A definitive root cause could not be identified 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
[145773114]
It was reported that on post-operative day one, linting (from the table cover) was discovered on the anterior chamber of patient's left eye. Patient required anterior chamber wash out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2019-00010 |
| MDR Report Key | 8491820 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-04-08 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TABLE COVER IN CATARACK PACK |
| Product Code | OJK |
| Date Received | 2019-04-08 |
| Catalog Number | DYNJ34123G |
| Lot Number | 18LBO845 |
| 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 | 2019-04-08 |