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

Lot Number	172135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec received the lens back for investigation.The lens was inspected at 15x magnification under a stereoscopic microscope.The lens was in three pieces, divided through the optic.When the pieces were placed together they made one complete lens.The cross-sectional inspection revealed jagged and rough edges indicative of cuts.No foreign material or particles were seen on the lens and no other defects were noted.We were unable to identify any grey coloring on the lens.After having carried out a detailed investigation of the device in question, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.Based on the results of the visual examination, lenstec was unable to identify any grey coloring on the returned lens or the three lenses from inventory.Lenstec has procedures in place to ensure that only devices which meet our final clean and inspection criteria would be shipped to our customers.Additionally, the cuts across the optic were made to facilitate removal of the lens from the eye.
Event or Problem Description
Lenstec, inc.Received an email notification stating "lens implanted on (b)(6) 2019 and when patient came back for day 1 post op the vision was checked and was not what it was supposed to be.Doctor noted lens had grey coloring to it.Explanted on (b)(6) 2019.Corneal edema noted.".

• 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: 8449141
• Report Number: 9613160-2019-00011
• Device Sequence Number: 10848959
• Product Code: HQL
• UDI-Device Identifier: 00844369027380
• UDI-Public: 00844369027380
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/25/2019

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: 06/25/2022
• Device Lot Number: 172135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1