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

Model Number	SOFTECHDO+18.0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
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.A supplemental report will be submitted once additional requested information is provided.
Event or Problem Description
Lenstec received an email stating " on (b)(6) 2022, cataract surgery was performed on the patient.After surgery, the lens had pigmented spots and the patient got intraocular inflammation".There was no patient injury or surgical intervention noted, lens remains implanted.
Event or Problem Description
Lenstec received an email stating " on (b)(6) 2022, cataract surgery was performed on the patient.After surgery, the lens had pigmented spots and the patient got intraocular inflammation".There was no patient injury or surgical intervention noted, 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.The assessment by the medical monitor stated that the cause, course, exact location, or appearance of the alleged spots are unknown and given the lack or prior batch/lot complaints or other red flags, the iols are less likely to be related.
Event or Problem Description
Lenstec received an email stating " on april 19, 2022, cataract surgery was perfromed on the patient.After surgery, the lens had pigmented spots and the patient got intraocular inflammation".There was no patient injury or surgical intervention noted, 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.The assessment by the medical monitor stated that the cause, course, exact location, or appearance of the alleged spots are unknown and given the lack or prior batch/lot complaints or other red flags, the iols are less likely to be related.

• Brand Name: SOFTEC HDO
• 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: 14492602
• Report Number: 9613160-2022-00008
• Device Sequence Number: 5836745
• Product Code: HQL
• UDI-Device Identifier: 00844369037273
• UDI-Public: 00844369037273
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2022

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: 07/25/2026
• Device Model Number: SOFTECHDO+18.0
• Device Catalogue Number: SOFTEC HDO
• Device Lot Number: 212420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 04/28/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/15/2022; 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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