MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-12 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Carl Zeiss Meditec Cataract Technology, Inc..
[189037301]
The device was discarded by the user facility and was not available for evaluation. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event. Capsular bag damage is listed in the device labeling as an inherent risk of cataract surgery. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189037302]
A male patient underwent cataract surgery in the left eye on (b)(6) 2020 where the miloop was used to section the cataractous lens into fragments. During the miloop portion of the procedure, the surgeon elected to bisect the lens without using a second instrument and the lens prolapsed into the anterior chamber. As the lens prolapsed, the capsular bag tore. The lens was removed, an anterior vitrectomy was performed, and the case was completed. The patient was reported as doing well postoperatively. Additional information was requested from the surgeon on (b)(6) 2020 to understand the relationship between the capsular damage and the miloop. The size of the capsulorhexis was approximately 4-5 mm and the cataract grade was estimated at 2+. The surgeon attributed the event to use error and there was no problem with the miloop device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2020-00002 |
| MDR Report Key | 9700966 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2018-12-17 |
| Date Added to Maude | 2020-02-12 |
| 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 | ED CONLEY |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO, NV |
| Manufacturer Country | US |
| Manufacturer Phone | 3797261 |
| Manufacturer G1 | CARL ZEISS MEDITECH CATARACT TECHNOLOGY, INC. |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO, NV |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILOOP LENS FRAGMENTATION DEVICE |
| Generic Name | OPHTHALMIC HOOK |
| Product Code | HNQ |
| Date Received | 2020-02-12 |
| Model Number | FG-11881 |
| Lot Number | FG20181207-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. |
| Manufacturer Address | 8748 TECHNOLOGY WAY RENO, NV US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |