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 2020-01-16 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Carl Zeiss Meditec Cataract Technology, Inc..
[189049080]
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. According to the surgeon, the posterior capsule tear could have occurred at any one of three times during the procedure: during the original sweep with miloop (a single bisection was performed). During irrigation/aspiration. During lens insertion - it was noted that the iol did not exit the delivery cartridge in the proper orientation and had to be rotated into position with a second instrument. The surgeon's subsequent surgeries with the miloop were uneventful. Capsular bag damage is an inherent risk of cataract surgery. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189049081]
A patient underwent cataract surgery in the right eye on (b)(6) 2019 where the miloop was used to section the cataractous lens into fragments. The surgeon noticed a tear in the posterior capsule after the intraocular lens was inserted into the capsular bag. An anterior vitrectomy was performed and the iol haptics were placed in the sulcus with the optic in the capsular bag; no sutures were required. The patient's one day postoperative visual acuity was 20/30. The relationship between the capsular damage and the miloop is not known. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2020-00001 |
| MDR Report Key | 9599340 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-16 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-08-01 |
| Date Added to Maude | 2020-01-16 |
| 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 NV 89521 |
| Manufacturer Country | US |
| Manufacturer Postal | 89521 |
| Manufacturer Phone | 7753797261 |
| Manufacturer G1 | CARL ZEISS MEDITECH CATARACT TECHNOLOGY, INC. |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO, NV 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 | 2020-01-16 |
| Model Number | FG-11881 |
| Lot Number | FG19072601 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-16 |