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

Model Number	SOFTECHD+21.0
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating " implanted, then realized a part of the haptic was torn and implanted another lens.No patient injury but incision enlarged to remove iol.".
Additional Manufacturer Narrative
The device has not arrived for inspection.Once the investigation is complete a supplemental report will be placed.
Additional Manufacturer Narrative
Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.Additionally, we have not received any other complaints from these batches.The damage to the lens suggests that the incorrect technique was used to load and eject the lens.Lenstec therefore recommends users to follow the instructions for use (ifu) for the correct procedures and technique to use when loading and ejecting the lens to ensure successful implantation.
Event or Problem Description
Lenstec received an email stating " implanted, then realized a part of the haptic was torn and implanted another lens.No patient injury but incision enlarged to remove iol.".

• 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: 17234159
• Report Number: 9613160-2023-00008
• Device Sequence Number: 7413529
• Product Code: HQL
• UDI-Device Identifier: 00844369027335
• UDI-Public: 00844369027335
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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 Model Number: SOFTECHD+21.0
• Device Catalogue Number: SOFTEC HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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