MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-17 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Carl Zeiss Meditec Cataract Technology, Inc..
[145411871]
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, the event was attributed to use error and there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling. Capsular bag damage and dropped nuclear fragments are inherent risks of cataract surgery [reference: schaal s, nesmith blw, ihnen ma, al-latayfeh m. Current medical and surgical management of retained lens fragments after cataract extraction. Us ophthalmic review 2014; 7 (2): 95-99]. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145411872]
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. After the first lens sectioning with the miloop, the surgeon had difficulty rotating the lens so company personnel suggested to the surgeon that one cut was sufficient and recommended not proceeding with a second cut. However, the surgeon elected to perform a second cut and inadvertently inserted the miloop too far posteriorly with the tip of the housing tube beyond the center of the capsule and the posterior capsule subsequently ruptured. Half of the lens dislocated into the vitreous and the other half was removed with anterior vitrectomy. A three-piece intraocular lens was implanted uneventfully and the patient was referred to a retina specialist to retrieve the lens fragment. Additional information was requested from the surgeon, who reports that retinal surgery was performed on (b)(6) 2019. The patient's initial postoperative best corrected visual acuity (bcva) was 20/40, improving to 20/30 at last examination on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2019-00005 |
| MDR Report Key | 8620833 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-22 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2019-05-17 |
| 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 | 2019-05-17 |
| Model Number | FG-11881 |
| 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 | 2019-05-17 |