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 2019-02-07 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Carl Zeiss Meditec Cataract Technology, Inc..
[135384968]
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. The surgeon provided the following root cause insight. The surgeon thought she may have been able to stabilize the lens if she had been able to use a second instrument, but she was not certain if that would have been enough to prevent zonular dehiscence. The surgeon believed the patient's dense cataract, the decision not to use a second instrument to stabilize the lens, and potentially pre-existing weak zonules contributed to the 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. Zonular dehiscence is an inherent risk of cataract surgery. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[135384969]
A female patient with a very dense 3+ nuclear sclerotic cataract and history of diabetes underwent cataract surgery on (b)(6) 2019 where the miloop device was used to section the cataractous lens into quadrants. The miloop was introduced through a temporal clear corneal incision and the first miloop cut to bisect the lens appeared typical. According to the surgeon, during the second cut the crystalline lens rotated and she had difficulty repositioning the lens; at this point the posterior capsular bag was suspended. The surgeon was uncertain whether the posterior bag had ruptured, but she thought there may have been complete zonular dehiscence. The surgeon performed pars plana posterior-assisted levitation and lifted the lens into the anterior chamber. A sheets glide was inserted into the eye, and the nuclear fragments were removed from the anterior chamber using a lens loop. The surgeon then performed a vitrectomy and implanted an anterior chamber intraocular lens. There were no retained nuclear fragments, and the patient was not referred to a retinal specialist. The following surgical details were provided: the resident created the paracentesis in a non-optimal location before the attending surgeon took over to perform the miloop portion of the procedure. As she had already performed successful single-handed miloop cases on the same day, she did not feel the need to create a secondary incision in a more appropriate location. This circumstance precluded use of a second instrument to stabilize the nucleus during the case. The surgeon thought the patient possibly had weak zonules, although this was not noted preoperatively. One week postoperatively the surgeon reports an improvement in corneal edema and hand motion vision. The patient will be examined in 3 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2019-00001 |
| MDR Report Key | 8315479 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-07 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2018-05-03 |
| Date Added to Maude | 2019-02-07 |
| 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 | 2019-02-07 |
| Model Number | FG-11881 |
| Lot Number | FG20180502-20 |
| 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 | 2019-02-07 |