MAUDE Adverse Event Report: LENSTEC BARBADOS INC. CART M; CARTRIDGE

Lot Number 194407

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

Lenstec can confirm that all procedures in the manufacturing and packaging of the cartridges was conducted correctly.Due to the absence of the cartridge and insertion device, lenstec was unable to perform a more thorough investigation of the complaint.We are therefore unable to determine a specific cause for the damage observed on the subsequent lens.Furthermore, lenstec confirms that the cartridge and inserter, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this cartridge and lens model.

Event Description

Lenstec received a complaint that the hdm lens shot out of an injector and cart m cartridge.Note: the facility did not return any "cartidge" or inserter for an evaluation by the manufacturer.

• Brand Name: CART M
• Type of Device: 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 ; 5712272
• MDR Report Key: 9885915
• MDR Text Key: 189505011
• Report Number: 9613160-2020-00009
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090022
• 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: 03/26/2020

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?: No
• Device Operator: Health Professional
• Device Lot Number: 194407
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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