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

Model Number SOFTECHDO+17.25

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

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

Event Date 06/23/2021

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 device had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.

Event Description

Lenstec received an email stating " lens torn during procedure.Incision enlarged to remove the lens from the eye with no patient injury and another lens was implanted.".

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 device had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.The investigation of the actual device yielded damage to the haptic that was caused by a device loading error thus the problem traced to the user not following the manufacturing instructions.

Event Description

Lenstec received an email stating " lens torn during procedure.Incision enlarged to remove the lens from the eye with no patient injury and another lens was implanted.".

• Brand Name: SOFTEC HDO
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 12220882
• MDR Text Key: 263378071
• Report Number: 9613160-2021-00018
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369037242
• UDI-Public: 00844369037242
• Combination Product (y/n): N
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOFTECHDO+17.25
• Device Catalogue Number: SOFTEC HDO
• Device Lot Number: 194134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1