MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977758

Device Problems Break (1069); Inaccurate Delivery (2339)

Patient Problems Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

The product was returned for analysis.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.The manufacturer internal reference number is: (b)(4).

Event Description

A health care professional reported with a description of cartridge broken during implantation two times and an iol (intraocular lens) could not be implanted.The patient left aphakic.Additional information has been received and stated that because f the burst cartridge zonulolysis more than 6 hours and iol explant needed and sulcus fixation not possible, nanophthalmus no sclera fixation possible.The patient was hospitalized as a result of this event.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received and stated that, one assumption of the customer was that the stamp was possibly bent and therefore slipped over or under the iol.

Manufacturer Narrative

A used company cartridge was returned sealed inside a large self sealing steripack pouch.Inadequate viscoelastic was observed inside the cartridge.Heavy stress lines were observed prior to and beyond the parting line.The nozzle was cracked along the right side of the cartridge.The damage began prior to the parting line in the thick nozzle cone wall and extended into the thinner tip material.The crack damage enlarged and split.The cartridge material at the end of the damaged tip area has become stretched and folded at the tip exit.The cartridge wings displayed evidence of being seated into a handpiece.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that a qualified lens and handpiece were used.A non-qualified viscoelastic was indicated.The root cause for the reported complaint may be related a failure to follow the ifu (instructions for use).A non-qualified viscoelastic was indicated.Per the ifu: the company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols (intraocular lens).Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The damage began in the thick nozzle cone wall on the anterior and travelled to the thinner tip area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.This type of damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.An inadequate amount of viscoelastic was also observed in the cartridge.The ifu instructs to completely fill the cartridge with ovd (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b )(4).

Event Description

Additional information received and stated that, the lens is loaded with the haptic stretched and an attempt is made to advance it with the plunger.This is not successful at first attempt.Viscoelastic is added again to advance the lens slightly.It hardly moves in the cartridge and cannot be advanced to the end with the plunger.On further attempt to advance, the lens moves anteriorly to the opening and is now placed in the anterior chamber with the plunger via the extended 3.0 incision.As the lens is advanced, the company cartridge tears longitudinally.The lens is implanted into the sulcus and cannot be retracted.The sharp edge causes a zonulolysis at 6 o'clock, so that the capsule cannot accommodate the lens in size and a capsular tension ring implantation is also not goal-directed due to the size of the zonula lesion.With extremely flat anterior chamber now non company viscoelastic and another company viscoelastic is entered to explant the lens haptic again and finally to cut the extremely thick lens with the lens scissors, a triangle is cut out, this with very flat anterior chamber, hardly in the anterior chamber maneuverable, thereby again and again iris incarceration, iris prolapse.Finally, the lens can be explanted, but the capsular bag cannot be held.Installation of a 2nd paracentesis, anterior vitrectomy and removal of the lens capsule.Placement of a suture 10.0 cross suture and 2 paracentesis sutures 10.0.Acetyl choline into the anterior chamber and smoothening of the incarcerated iris, above clearly frayed iris and medium wide pupil.Aspiration of the viscoelastic.Hydration of the phaco-tunnel and paracenteses.Filling of the anterior chamber with bss (balanced salt solution).Administration of antibiotic 0.1 ml into the anterior chamber.Entry of a antibiotic soaked bandage lens due to epithelial roughening.Intraoperative administration of parabular anesthesia and analgesic in painful patient.During manipulations iris basis hemorrhage, which can be finally situated and mainly aspirated.The patient got therapy with prednisolone 50 mg for 3 days, bf049 phacoemulsification without lens implantation, isolated in- and explantation of the lens.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13513997
• MDR Text Key: 285461871
• Report Number: 1119421-2022-00240
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777585
• UDI-Public: 00380659777585
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K001157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 8065977758
• Device Lot Number: 32610058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 02/14/2022; 04/21/2022; 08/11/2022
• Supplement Dates FDA Received: 03/07/2022; 05/18/2022; 09/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF SINGLEPIECE IOL; ACRYSOF SINGLEPIECE IOL; BSS STERILE IRRIGATING SOLUTION; GRIESHABER SCISSORS/TIPS, UNSPECIFIED; HEALON5; MONARCH II IOL DELIVERY SYSTEM, INJECTOR; OPHTEIS 1.0 (+1.8 INTRACAMERAL); OPHTEIS 1.0 (+1.8 INTRACAMERAL)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female