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

Lot Number	130646
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation was carried out using the stereoscopic microscope set to 20x magnification.The lens was returned in one piece.However, parts of both haptics were missing.The surfaces of the breaks on both haptics were smooth.There was also a jagged break running from the edge of the optic to the center of the optic.No foreign material or other damage was seen to the lens.The smooth breaks on the haptics suggest that they broke whilst in a dehydrated, or partially dehydrated, state.The jagged break on the optic suggests that it tore during manipulation of the device.This investigation revealed that the haptics of the lens broke due to manipulation of the device in a dehydrated, or partially dehydrated, state.Instruction for use supplied with the lens reinforces that the device should be kept hydrated to avoid damage.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 had been carried out correctly.Batch reconciliation was 100%.
Event or Problem Description
Lenstec received an email stating that "haptic was torn.".

• Brand Name: SOFTEC HDO
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 8524412
• Report Number: 9613160-2019-00012
• Device Sequence Number: 1871112
• Product Code: HQL
• UDI-Device Identifier: 00844369037372
• UDI-Public: 00844369037372
• Combination Product (Y/N): N
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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: 02/06/2018
• Device Lot Number: 130646
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2013
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1