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

Lot Number	182447
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	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigational results revealed no discrepancies found as it relates to the batch documentation analysis.The audit determined that all procedures in the manufacturing and packaging of the lens had been carried out correctly.Batch reconciliation was 100%.The lens inspection was performed at 15x magnification using a stereoscopic microscope.The returned lens consisted of the optic, one intact haptic and the 3/4 part of the other haptic which appeared smooth on the broken cross-sectional area.This suggests that the haptic broke whilst in a dehydrated state.On the optic a deep scratch was seen; which occurred during the removal of the lens.No foreign materials or particles were seen on the lens.The lens appeared to be handled whilst in a dehydrated state and caused the break at the haptic end.For this reason, lenstec recommends the ifu is followed and be implanted within two minutes of removal from the vial.(b)(4).
Event or Problem Description
Lenstec, inc.Received an email notification stating "during insertion the trailing haptic tore off.Incision was enlarged and lens was removed.Another hd +20.0 was inserted.Stitches were used and no adverse event for the patient".

• 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: 8323556
• Report Number: 9613160-2019-00004
• Device Sequence Number: 1691927
• Product Code: HQL
• UDI-Device Identifier: 00844369027298
• UDI-Public: 00844369027298
• 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): 02/07/2019

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: 07/09/2023
• Device Lot Number: 182447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1