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

Model Number	SOFTECHD+21.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Furthermore, the lens was destroyed at the facility thus a thorough investigation cannot be performed.However, lenstec has conducted extensive testing on this model, both during design and manufacturing process.Additionally, lenstec is unable to comment on the suitability of the cartridge used.
Event or Problem Description
Lenstec, inc.Received an email notification stating "lens tore upon insertion, incision enlarged to remove the lens and there was no patient injury".

• 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: 10084061
• Report Number: 9613160-2020-00048
• Device Sequence Number: 11478479
• Product Code: HQL
• UDI-Device Identifier: 00844369027335
• UDI-Public: 00844369027335
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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: 09/28/2020
• Device Model Number: SOFTECHD+21.0
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: F3918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1