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

Model Number	SOFTECHDO+18.0
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No discrepancies were found as it relates to the batch documentation analysis.The audit determined that all procedures in the manufacturing and packaging of the device has been carried out correctly.Batch reconciliation was 100%.The lens was inspected under a stereoscopic microscope at 30x magnification.The lens carries a broken haptic.The returned piece of the lens appeared smooth on the broken cross section area.This suggests that the haptic broke whilst in a dehydrated state.The cartridge and lens are compatible for implantation.Lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.The lens appeared to be handled whilst in a dehydrated state and this caused the break at the haptic.
Event or Problem Description
Lenstec, inc.Received an email notification stating "the device was being returned as it was explanted due to a torn haptic during insertion.".

• 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: 10106468
• Report Number: 9613160-2020-00053
• Device Sequence Number: 14277276
• Product Code: HQL
• UDI-Device Identifier: 00844369037273
• UDI-Public: 00844369037273
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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: 12/17/2020
• Device Model Number: SOFTECHDO+18.0
• Device Catalogue Number: SOFTEC HDO
• Device Lot Number: 154812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1