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

Model Number SOFTECHD+20.0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 07/28/2021

Event Type  Injury  

Event Description

Lenstec received an email stating "the patient has toxin anterior segment syndrome after surgery on (b)(6) 2021 in (b)(6) hospital, and the lens was explanted on (b)(6) 2021 in the (b)(6) ".No back up lens implanted and there was no patient injury or surgical intervention noted.

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%.The device was reported to be explanted but not returned to lenstec.Lenstec can also confirm that there have never been any confirmed lens-related cases of tass of our hema lenses.There is no evidence to suggest that any aspect of this device was responsible for the reported inflammation.A supplemental report will be submitted once a medical monitor assessment is complete.

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%.The device was reported to be explanted but not returned to lenstec.Lenstec can also confirm that there have never been any confirmed lens-related cases of tass of our hema lenses.The medical monitor also concludes there is no evidence to suggest that any aspect of this device was responsible for the reported inflammation.

Event Description

Lenstec received an email stating " the patient has toxin anterior segment syndrome after surgery on (b)(6) 2021 in (b)(6) hospital, and the lens was explanted on (b)(6) 2021 in (b)(6)".No back up lens implanted and there was no patient injury or surgical intervention noted.

• 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: 13179473
• MDR Text Key: 288289659
• Report Number: 9613160-2022-00002
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027298
• UDI-Public: 00844369027298
• 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,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOFTECHD+20.0
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 211805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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