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

Model Number	SOFTECHD+20.0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
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 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.
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 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 or Problem 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
• 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 ; 7275712272
• MDR Report Key: 13179473
• Report Number: 9613160-2022-00002
• Device Sequence Number: 4486021
• Product Code: HQL
• UDI-Device Identifier: 00844369027298
• UDI-Public: 00844369027298
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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 Expiration Date: 06/02/2026
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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