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

Model Number SOFTECHD+18.0

Device Problem Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

No discrepancies were found as it relates to the batch documentation analysis.The audit determined that all procedures in the manufacturing and packaging of the device has been carried out correctly.Batch reconciliation was 100%.The lens was inspected under a stereoscopic microscope at 30x magnification.Both haptics were missing.The returned piece (optic) of the lens appeared smooth on the broken cross section area.This suggests that the haptic broke whilst in a dehydrated state.No foreign material or defects were seen on the lens.The cartridge and lens are compatible for implantation.Lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.The lens appeared to be handled whilst in a dehydrated state and this caused the break at the haptic.

Event Description

Lenstec, inc.Received an email notification stating "the device was being returned as it was explanted because of a haptic tear.".

• Brand Name: SOFTEC HD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92,; BB BB17092,
• 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: 10106462
• MDR Text Key: 193316460
• Report Number: 9613160-2020-00052
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027212
• UDI-Public: 00844369027212
• 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: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: SOFTECHD+18.0
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 165073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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