MAUDE Adverse Event Report: MORCHER STUTTGART GMBH REFORM CAPSULAR TENSION RING; RING, ENDOCAPSULAR

Model Number ACTR11

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

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

Event Description

A facility representative reported with a description of manufacture defective intraocular lens (iol).Additional information has been requested, received and stated scrub tech loaded capsular tension ring (ctr) correctly.When the surgeon inserted the ctr one of the loops was missing/cut off.It was replaced with new ctr during initial procedure.There was no harm to the patient.

Manufacturer Narrative

Correction information was provided in d.4.And h.4.On initial mdr the lot number was inadvertently not added.It is added in this report.The review of the device history record (dhr) of lot showed no irregularities or deviations.All released rings met their dimensions according to the review of the measurement protocols.A product examination could not be made due to the product was not returned.Hygienic condition of the product: unknown, the product was not returned.Due to our internal 100% visual inspection we exclude that a broken ring has been sealed into the sterile packaging and sent to the vendor.The reason of complaint is not detectable.We suspect that user related factors such a handing or loading techniques have contributed to the event.The root cause may linked to the user to ensure an adequate investigation, we recommend the return of claimed product and the investigation regarding the injector/instruments (eg.Manufacturer, type) which was used.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened product packaging of capsular tension ring (ctr) from labelled lot and serial number was returned.The product and primary packaging are missing.A review of the complaints from the participating facility revealed that a significant number of complaints with the same defect were reported since 2023.The manufacturer internal reference number is: (b)(4).

• Brand Name: REFORM CAPSULAR TENSION RING
• Type of Device: RING, ENDOCAPSULAR
• Manufacturer (Section D): MORCHER STUTTGART GMBH; kapuzinerweg 12; stuttgart 70374 ; GM 70374
• Manufacturer (Section G): MORCHER STUTTGART GMBH; kapuzinerweg 12; stuttgart 70374 ; GM 70374
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17470227
• MDR Text Key: 320710987
• Report Number: 1610287-2023-00035
• Device Sequence Number: 1
• Product Code: MRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACTR11
• Device Catalogue Number: ACTR11
• Device Lot Number: CCMACC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female