MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC HD; INTRAOCULAR LENS

Model Number SOFTECHD+20.5

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2023

Event Type  Injury  

Event Description

Lenstec received an email stating " one loop of the lens was broken, there is a fracture with a length of about 5mm and a width about 1mm.The lens was implanted and the patient is fine'.

Manufacturer Narrative

Based on the assessment of our batch documentation review, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.Additionally, we have not received any other complaints from this batch.There was no evidence to suggest that any aspect of this device was responsible for the reported broken haptic.Lenstec confirms that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Furthermore, lenstec is unable to comment on the compatibility the use of a ve2200 injector used.

• Brand Name: SOFTEC HD
• Type of Device: INTRAOCULAR LENS
• 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: 16940252
• MDR Text Key: 315312264
• Report Number: 9613160-2023-00006
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027311
• UDI-Public: 00844369027311
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOFTECHD+20.5
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 223510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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