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

Lot Number	SB16345
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)
Date of Event	03/10/2024
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 reported remains implanted and therefore, not returned to lenstec.Lenstec can also confirm that there have never been any confirmed lens-related cases of "white membrane like ground glass appeared on the surface of the lens after surgery" of our hema lenses.All endotoxin testing met specifications.There is no evidence to suggest that any aspect of this device was responsible for the reported event.Additional assessment by the medical monitor is ongoing, once completed a supplemental report will be submitted.
Event or Problem Description
Lenstec received an email stating "white membrane like ground glass appeared on the surface of the lens after surgery.".
Event or Problem Description
Lenstec received an email stating, "white membrane like ground glass appeared on the surface of the lens after surgery".
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 reported remains implanted and therefore, not returned to lenstec.Lenstec can also confirm that there have never been any confirmed lens-related cases of "white membrane like ground glass appeared on the surface of the lens after surgery" of our hema lenses.All endotoxin testing met specifications.There is no evidence to suggest that any aspect of this device was responsible for the reported event.

• 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: 19159509
• Report Number: 9613160-2024-00026
• Device Sequence Number: 7861907
• Product Code: HQL
• UDI-Device Identifier: 00844369027335
• UDI-Public: 00844369027335
• 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: 2024
• 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): 05/23/2024

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: SB16345
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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