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

Lot Number	172043
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After thorough investigation by the quality systems department, the results of lenstec's investigation are as follows: lens was discarded during procedure thus no device investigation was possible.Furthermore, lenstec was unable to sample any devices from the batches as all devices have been sold.Additionally, there were no previous complaints received from these batches.Lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Due to the absence of the lens, lenstec was unable to perform a more thorough investigation of the complaint.We are therefore unable to conclude what may have taken place which would have caused the damaged haptic; however, this device is compatible with the lc 16 cartridge.The instructions for use provided with the lens indicates the correct method for implantation and lenstec advises that the user follows these instructions which have been validated to prevent damage to the lens.(b)(4).
Event or Problem Description
Lenstec, inc.Received an email notification stating "upon insertion the trailing haptic tore off.Incision size was increased and lens was removed.Lens was discarded during procedure.Another +16.25 lens was implanted, stitches were placed at the time.No adverse event with the patient on re-exam next day".

• 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: 8143206
• Report Number: 9613160-2018-00036
• Device Sequence Number: 11198897
• Product Code: HQL
• UDI-Device Identifier: 00844369027694
• UDI-Public: 00844369027694
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2018

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: 06/19/2022
• Device Lot Number: 172043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1