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

Lot Number 231920

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/26/2024

Event Type  Injury  

Event Description

Lenstec received an email stating " that in the last week, (b)(6) hospital had 3 patients present postoperatively with severe inflammation".The lens remains 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%.The device was reported as remains implanted and therefore, 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.Literature surrounding tass implicates bacterial detritus often attributed to inadequate flushing of surgical instruments - particularly those with lumen, such as cannulae.Bacterial detritus can be quantitated using an "endotoxin" test, and this is a required test for every batch of lenses that lenstec produces.The applicable limit for endotoxin for intraocular lenses is described in iso 11979-8, and is 0.2eu/device.Lenstec's has adopted a much more stringent limit for endotoxin of 0.12eu/device.Each of the three batches listed above was tested and found to comply with this limit, indicating that it is extremely unlikely that the product could have caused a non-infective reaction such as tass.

• 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
• MDR Report Key: 18975482
• MDR Text Key: 338557691
• Report Number: 9613160-2024-00009
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027311
• UDI-Public: 00844369027311
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 231920
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2023
• 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