MAUDE Adverse Event Report: 1211998 ANTERIOR CHAMBER CANNULA (RYCROFT), .30 X 22 MM (30G X 7/8 IN); MANULA OPHTHALMIC SURGIAL INSTRUMENT

Catalog Number 581273

Device Problem Connection Problem (2900)

Patient Problem Eye Injury (1845)

Event Date 02/28/2018

Event Type  Injury  

Event Description

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.

• Brand Name: ANTERIOR CHAMBER CANNULA (RYCROFT), .30 X 22 MM (30G X 7/8 IN)
• Type of Device: MANULA OPHTHALMIC SURGIAL INSTRUMENT
• Manufacturer (Section G): 1211998; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer Contact: genci omari ; 500 totten pond rd; 10 city point; waltham, MA 02451 ; 7819066925
• MDR Report Key: 8565252
• MDR Text Key: 143579765
• Report Number: 1211998-2018-00001
• Device Sequence Number: 1
• Product Code: HMX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 581273
• Device Lot Number: 3210649
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention