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

Model Number	SOFTECHD+23.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/07/2021
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%.Due to the absence of the lens, lenstec was unable to perform a more thorough investigation of the complaint.Lenstec is unable to comment on the compatibility of the blis-r1 injector and blis cartridge used and recommends that the user follow the instructions for use provided with the lens which indicates the compatible instruments and procedure for correct implantation of the lens.
Event or Problem Description
Lenstec, inc.Received an email notification stating "haptic tore during insertion.Lens cut and removed.Was not able to locate lens.Capsule broke during the process of cleaning out the viscoelastic and preparation for insertion of the same model lens.An interior chamber lens had to be used instead." the b+l (blis-r1) injector and blis cartridge were the instruments used.

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92,; BB BB17092,
• MDR Report Key: 12364913
• Report Number: 9613160-2021-00021
• Device Sequence Number: 17277221
• Product Code: HQL
• UDI-Device Identifier: 00844369027410
• UDI-Public: 00844369027410
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: 08/29/2024
• Device Model Number: SOFTECHD+23.0
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 192655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1