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

Lot Number	SB05462
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	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned for evaluation.The three pieces of the lens was inspected under a stereoscopic microscope at 15x magnification.The first piece consisted of an intact haptic and approximately half of the optic, the second piece was approximately one half of the optic and the third piece was the second haptic.When the pieces were placed together, they made a complete lens.The cross-sectional inspection of the optic areas appeared jagged and rough and several dig outs were also seen.This damage is indicative of a cut to facilitate the removal of the lens from the eye.The cross-section inspection of the broken haptic area appeared smooth suggesting that the haptic broke whilst in a dehydrated state.The ifu explains the proper procedure for implanting the lens prior to the lens dehydrating.Lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.
Event or Problem Description
Lenstec received an email stating that "back haptic torn, noted by surgeon as lens was inserted.Lens was removed, new lens was used.Incision enlarged to remove iol and no patient injury noted".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 8524413
• Report Number: 9613160-2019-00014
• Device Sequence Number: 1966018
• Product Code: HQL
• UDI-Device Identifier: 00844369027403
• UDI-Public: 0844369027403
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/17/2019

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: 12/17/2023
• Device Lot Number: SB05462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• 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