MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2019-04-30 for ANTERIOR CHAMBER CANNULA (RYCROFT), .30 X 22 MM (30G X 7/8 IN) 581273 manufactured by .
[143579764]
.
Patient Sequence No: 1, Text Type: N, H10
[143579765]
It was reported by the customer that the anterior chamber cannula [rycroft] disconnected from the leur-lok syringe. The customer stated, "that towards the end of the cataract surgery while flushing with balance salt solution (bss) the cannula flew off and embedded into the patient's eye. " through the investigation it was stated, "the tech in-training secured the cannula with the protective sheath rather than securing it by hand. " a medwatch report mw5076312 report stated, "the left eye was prepped and draped for ophthalmic surgery and surgical procedure began. Cataract extraction was performed and iol + 19. 05 (b)(4) was introduced. During the hydration of the temporal wound, the cannula disconnected from the syringe and entered the anterior chamber, breaking the posterior capsular bag. This caused dislocation of the implanted iol which then receded into the vitreous cavity. Eye was evaluated by surgeon, wounds were re-checked and no additional procedure was required at that time. Gatifloxacin and prednisolone drops were given prior to patching. Patch placed over surgical site and patient transferred to post-op holding area. On re-assessment 2 days later - thick heme overlying the macula and optic nerve. " no further information has been provided for this event or investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1211998-2018-00001 |
| MDR Report Key | 8565252 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-26 |
| Date of Event | 2018-02-28 |
| Device Manufacturer Date | 2017-07-24 |
| Date Added to Maude | 2019-04-30 |
| 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 | MR. GENCI OMARI |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITY POINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7819066925 |
| Manufacturer G1 | 1211998 |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTERIOR CHAMBER CANNULA (RYCROFT), .30 X 22 MM (30G X 7/8 IN) |
| Generic Name | MANULA OPHTHALMIC SURGIAL INSTRUMENT |
| Product Code | HMX |
| Date Received | 2019-04-30 |
| Model Number | NA |
| Catalog Number | 581273 |
| Lot Number | 3210649 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-30 |