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 2019-03-26 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Carl Zeiss Meditec Cataract Technology, Inc..
[139878948]
The device was discarded by the user facility and is 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. Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling. The relationship between the event and the device is unknown and no surgical video is available for analysis. Capsular bag damage and vitreous loss are inherent risks of cataract surgery. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139878949]
A (b)(6) year-old female patient with a grade 3+ nuclear sclerotic cataract underwent cataract surgery on (b)(6) 2019 where the miloop device was used to section the cataractous lens into quadrants. After the first successful bisection, the surgeon removed the miloop from the eye, rotated the lens with a drysdale nucleus manipulator (storz), then reinserted the miloop and made the final lens cut. After removing the first 2 lens quadrants, the surgeon noticed a small posterior capsule tear at the 9:00 position (left eye, temporal incision) and vitreous loss. A vitrectomy was performed and a sulcus-fixated intraocular lens was implanted. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2019-00003 |
| MDR Report Key | 8452743 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-26 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-04-22 |
| Device Manufacturer Date | 2018-05-14 |
| Date Added to Maude | 2019-03-26 |
| 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 | JANE DEMKOVICH |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO NV 89521 |
| Manufacturer Country | US |
| Manufacturer Postal | 89521 |
| Manufacturer Phone | 7754731014 |
| Manufacturer G1 | CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO NV 89521 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 89521 |
| 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 | 2019-03-26 |
| Model Number | FG-11881 |
| Lot Number | FG20180514-20 |
| 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 89521 US 89521 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-26 |