MAUDE Adverse Event Report: LENSTEC BARBADOS INC. CART45S; LENS INJECTOR CARTRIDGE

Lot Number 213901

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the lens and cartridge had been conducted correctly.Batch reconciliation was 100.0%.The visual inspection performed on the devices determined that the lens and cartridge were returned intact, with no damage or defects present.An injection test was performed using the returned lens and cartridge and the lens was ejected from the cartridge as expected without any damage or defects.In relation to the cartridge being tight upon insertion, this could have been a result of the way the lens was loaded and recommends the user follow the ifu for correct procedures for loading and ejecting the lens.

Event Description

Lenstec received an email stating " md wanted a new lens loaded after attempting to insert the lens.Another lens was successfully implanted.The issue was not with the lens, but the cartridge felt tight upon insertion".

• Brand Name: CART45S
• Type of Device: LENS INJECTOR CARTRIDGE
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 13168230
• MDR Text Key: 283242485
• Report Number: 9613160-2022-00001
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 213901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2021
• 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