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

Lot Number	173314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/19/2018
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 inspection was performed at 10x magnification using a stereoscopic microscope.The lens was in two pieces, divided by a cut through the center of the optic.The cross-sectional inspection revealed smooth and straight edges and appeared to have been made by a sharp instrument.This cut was probably made to facilitate removal of the lens from the eye.Both haptics were intact.No foreign materials or particles were seen on the lens.There was no evidence to suggest that any aspect of the lens was responsible for the patient not seeing properly.(b)(4).
Event or Problem Description
Lenstec, inc.Received an email notification stating "lens was implanted (b)(6) 2018 and explanted on (b)(6) 2018.Patient complaint of not seeing properly.Doctor removed lens and implanted hd +19.25, made an incision to remove and replaced the lens without needing sutures and no adverse event with 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: 8262866
• Report Number: 9613160-2019-00003
• Device Sequence Number: 1672697
• Product Code: HQL
• UDI-Device Identifier: 00844369027410
• UDI-Public: 00844369027410
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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: 11/12/2022
• Device Lot Number: 173314
• 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: 12/19/2018
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1