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

Lot Number	S10498
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	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on our investigation of the returned devices and our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lenses were conducted correctly.The visual examination carried out showed that the cut across both optics were most likely done to facilitate removal of the lenses from the eye.The scratches seen on both optics appeared to be from incorrect loading/handling.The instructions for use provided with each lens indicates the correct method for handling and implantation of the lens, and lenstec advises that the user follows these instructions which have been validated to prevent damage to the lens.Lenstec has also conducted extensive testing on the lens model and the cartridge used and our results indicate that these devices are compatible.(b)(4).
Event or Problem Description
Lenstec, inc.Received an email notification stating "implanted lens and dr.Noticed it was cracked and torn.Explanted and put in like lenstec iol.No injury to patient.".

• Brand Name: SOFTEC HDO
• 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: 8363864
• Report Number: 9613160-2019-00009
• Device Sequence Number: 16625300
• Product Code: HQL
• UDI-Device Identifier: 00844369027298
• UDI-Public: 00844369027298
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 02/15/2023
• Device Lot Number: S10498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1