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

Lot Number	171256
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec received an e-mail notification stating a lens had "folding/ unfolding" issues and "stuck in delivery device" and the platinum inserter was used.The lens was received dry in the vial, the cap was on the vial but the bung was absent.The internal vial delivery system, outer pouch and instructions for use were also absent, but the label set and id card were enclosed in the outer box.The visual examination was carried out using the stereoscopic microscope set to x20 magnification.The lens carried a cut through the optic; one area of the cut was jagged and it appeared that multiple attempts were made.This was probably made to facilitate removal of the lens from the eye.One of the haptics was broken and the cross-sectional inspection revealed a jagged break.The lens was covered in foreign substance - this appeared to be dried saline crystals and viscoelastic.No other defects were noted.The lens was hydrated and a further inspection performed - the foreign substances were removed.No discrepancies were found as it relates to the batch documentation analyses.The audit determined that all procedures in the manufacturing and packaging of the device had been carried out correctly.Batch reconciliation was 100%.With regards to the optic and the damaged haptic, lenstec concludes that the damage was because of the removal process of the lens from the eye.Additionally, lenstec is unable to comment on the suitability of the instruments used by the surgeon with the softec hd lens.
Event or Problem Description
Lenstec received an email stating "folding/unfolding issues", "stuck in the delivery device".

• 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: 7170637
• Report Number: 9613160-2018-00009
• Device Sequence Number: 13707184
• Product Code: HQL
• UDI-Device Identifier: 00844369027304
• UDI-Public: 00844369027304
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2018

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: Physician
• Device Expiration Date: 05/03/2022
• Device Lot Number: 171256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 01/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1