MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR

Model Number III

Device Problem Device-Device Incompatibility (2919)

Patient Problem Corneal Edema (1791)

Event Type  Injury  

Manufacturer Narrative

Product evaluation: no injector was returned for evaluation for the report of damage to the haptic that caused corneal edema; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.Because an injector sample was not returned and no lot information was provided, the root cause for the customer complaint issue cannot be determined.Additional information has been requested.(b)(4).

Event Description

A material's manager reported the intraocular lens (iol) trailing haptic was nicked.The representative indicated the event was ¿likely related to the injector cutting the training haptic¿.The representative also indicated ¿the prolonged surgery caused corneal edema that has not fully resolved yet.Unknown if this is will resolve on its own.".

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).

Manufacturer Narrative

One handpiece injector was returned for evaluation for the report of the lens trailing haptic being nicked.The lens was also returned.A review of the injector device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.The handpiece injector was manufactured in february 2016.The manufacturing review of the iol met specification.No lot number was provided for the cartridge.A visual inspection of the handpiece injector was performed and deemed nonconforming.The plunger has an upward visual position.A functional thread to barrel engagement check was performed and deemed conforming.A dimensional plunger position height check was performed and deemed nonconforming.The plunger position height is extremely high.The lens was returned taped to a piece of paper with the lens case lid.Viscoelastic is observed.One haptic is broken-gusset and distal area (distal portion returned).The optic is cut into two pieces.A functional test was performed with the injector and deemed nonconforming.The plunger was not able to impact the ramp due to the extremely high plunger position.The evaluation does confirm the injector has a nonconforming bent plunger condition.The root cause for how and when the high plunger position occurred cannot be determined from this evaluation.The most likely reason for the upward plunger bend position is due to handling and care by the customer.A high plunger position will increase the likelihood of a poor lens delivery and causing damage to the lens.(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: 7025340
• MDR Text Key: 91827987
• Report Number: 2523835-2017-00769
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 139972M
• Other Device ID Number: 00380659777738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Date Device Manufactured: 02/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGE; UNSPECIFIED VISCOAT
• Patient Outcome(s): Other