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

Lot Number	180510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The lens was hydrated and the foreign particles were removed on further inspection.No other defects were noted.Lenstec was unable to sample any lenses from the batch as all devices have been sold.Additionally, there were no previous complaints received from this batch.A full audit of all batch documentation relating to the production of the lens was performed.The audit concluded that all procedures in manufacturing and packaging of the lens had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.In terms of the investigation, the defect seen was probably because of removing the lens from the eye.There was no evidence to suggest that any aspect of the lens was responsible for the vision loss experienced after surgery.Lenstec is therefore unable to determine a specific cause for this incident.Additionally, lenstec believes that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Furthermore, lenstec is unable to comment on the suitability of the monarch iii d cartridge used.Lenstec therefore recommends that the user follow the instructions for use provided with the lens which indicates the compatible instruments and the procedure for correct implantation of the lens.
Event or Problem Description
Lenstec, inc.Received an email stating "decreased visual acuity.Implanted 3-piece lens.".

• Brand Name: SOFTEC I
• 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: 7541116
• Report Number: 9613160-2018-00024
• Device Sequence Number: 1861268
• Product Code: HQL
• UDI-Device Identifier: 00844369029483
• UDI-Public: 00844369029483
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/23/2018

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: 02/19/2023
• Device Lot Number: 180510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1