MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC

Catalog Number 8065420020

Device Problem Detachment Of Device Component (1104)

Patient Problem Vitreous Loss (2142)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A company representative reported that an anterior chamber cannula flew off in the patient's eye and caused a vitreous hemorrhage.The nurse and surgeon checked it was on tight before using in patient's eye.When pressure was put through while hydrating the stroma during a cataract procedure, the cannula came off in the patient's eye and caused a bleed in the eye (vitreous hemorrhage).They could not see where the blood was coming from as the eye was red.The procedure was complete and the patient required an anterior vitrectomy.The patient will be returning for a second evaluation on a further date.No other information available.Additional information has been requested and received.

Manufacturer Narrative

Cannula product evaluation no lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.One opened cannula was received for evaluation.The sample was visually inspected and was found conforming and no foreign matter was observed inside the hub or the cannula.The sample was then functionally tested for air flow and was found non-conforming.No foreign matter was observed in the cannula after air flow testing.The sample was then functionally tested for fit with syringe and luer taper and was found conforming for both functional tests.Root cause: the evaluation confirmed that the cannula was occluded, which would cause back pressure and could cause the cannula to pop off of the syringe as was reported.The returned sample was returned opened, therefore how and when the cannula tip became blocked cannot be determined from this evaluation and an exact root cause cannot be determined for the complaint as described by the customer.The complaint file states that the cannula was used in surgery prior to coming off of the syringe, therefore, a potential contributing factor would be procedural residue being introduced into the cannula, causing the blockage.The complaint file also states that there is ¿suspected user error¿ during the use of the product, which would be another potential contributing factor of the defect seen.Syringe product evaluation: device history record review is not possible since no lot was provided.A complaint history check was performed and this is the first complaint for this contract, component and type of event in a period of one year.As a complaint sample a syringe 3 millimeter (ml) was received.The screw thread of the luer lock did not show any damage.The syringe was filled with water and a cannula was attached.The cannula did not flow off when the water was released.The root cause was found inconclusive ¿ unable to verify.No lot available, no detailed investigation of the root cause is possible.Investigation of the complaint sample (syringe) could not confirm the complaint.Investigation of the complaint sample (cannula) confirmed the cannula was occluded.The most potential root causes are: external ¿ material supplier related -- the syringes are supplied to the manufacturer by a third party suppler and added to the custom-pak product.No visual or functional inspection of the syringes is performed prior to assembly of the custom-pak product.Evaluation of the sample (syringe) could not confirm the complaint.Also no lot number of the syringe is available.Therefore no quality remark will be forwarded to the supplier.The cannulas are supplied to the manufacturer in a package.The packed cannulas are added as such to the custom-pak product.No visual or functional inspection of the cannulas is performed prior to assembly of the custom-pak product.External ¿ use error -- it is also possible that the customer did not use the cannula/syringe correctly, this was stated in the complaint file.In the complaint description the sales representative suspects user error.(b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
• Type of Device: CANNULA, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7169650
• MDR Text Key: 96582774
• Report Number: 2523835-2018-00010
• Device Sequence Number: 1
• Product Code: HMX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065420020
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other; Required Intervention
• Patient Age: 83 YR