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..
[139877635]
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 primary cause of the zonular tear was attributed to the patient's preexisting conditions (e. G. , dense cataract, weak zonules, and pseudoexfoliation, etc. ). The surgeon stated that it was likely that the weak zonules would not have survived any other surgical technique to remove the nucleus, including small incision cataract surgery, extracapsular cataract extraction, or phacoemulsification. Zonular dehiscence is an inherent risk of cataract surgery. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139877636]
A (b)(6) year-old monocular patient with a very dense brunescent grade 4+ nuclear sclerotic cataract, pseudoexfoliation, and weak zonules underwent cataract surgery on (b)(6) 2019 where the miloop device was used in an attempt to section the cataractous lens into quadrants. The patient had a complex ocular history in the operative eye that included end-stage glaucoma, advanced macular degeneration, and limited light perception vision (in addition to the dense cataract, pseudoexfoliation, and weak zonules). Given the medical history, the surgeon's goal for cataract surgery was to try to achieve ambulatory vision. The surgeon reports he was hoping to use the miloop to section the nucleus to make phacoemulsification easier; however, he experienced difficulty capturing the nucleus due its very large size. When the nucleus tipped during manipulation, it became apparent that the zonules had torn. The procedure was subsequently aborted and the patient was referred to a retina specialist who performed surgery approximately 45 minutes later. No intraocular lens (iol) was implanted and the patient is being fitted for aphakic spectacles (no iol implantation is planned). The patient's prognosis is good. At the one day postoperative visit, the patient's bcva improved to count fingers in the periphery and the patient was happy with this improvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2019-00002 |
| MDR Report Key | 8452666 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2018-05-03 |
| 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 | FG20180502-20 |
| 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 |