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

Lot Number	232446
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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: 18975486
• Report Number: 9613160-2024-00011
• Device Sequence Number: 6694188
• Product Code: HQL
• UDI-Device Identifier: 00844369027359
• UDI-Public: 00844369027359
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: 232446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown