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

Lot Number	161307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in the vial enclosed in a biohazard bag.The cap and bung were present but no other lenstec packaging was returned.The inspection was performed at 10x magnification using a stereoscopic microscope.The lens was in two pieces, separated by the optic and when placed together, a complete lens was formed.The cross-sectional inspection revealed smooth and straight edges and appeared to be a cut made by a sharp instrument.This cut was probably made to facilitate removal of the lens from the eye.There were some scratches and an additional cut in the lens material around the area where the lens was separated.No other defects were noted.The dimension testing revealed that the lens was found to be within specification.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 defects seen were probably as a result of removing the lens from the eye.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.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.Once any additional information is received a supplemental report will be submitted.
Event or Problem Description
Lenstec received via email a notification stating "patient was complaining after 2 months that they could not see very well.Doctor removed the lens and implanted another lens from another manufacturer.There was no adverse event with the patient.Patient complained of glare, rim artifact.".
Additional Manufacturer Narrative
The lens was returned in the vial enclosed in a biohazard bag.The cap and bung were present but no other lenstec packaging was returned.The inspection was performed at 1ox magnification using a stereoscopic microscope.The lens was in two pieces, separated by the optic and when placed together, a complete lens was formed.The cross-sectional inspection revealed smooth and straight edges and appeared to be a cut made by a sharp instrument.This cut was probably made to facilitate removal of the lens from the eye.There were some scratches and an additional cut in the lens material around the area where the lens was separated.No other defects were noted.The dimension testing revealed that the lens was found to be within specification.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 defects seen were probably as a result of removing the lens from the eye.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.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.Medical monitor assessment has been added as supplemental information.
Event or Problem Description
Lenstec received via email a notification stating "patient was complaining after 2 months that they could not see very well.Doctor removed the lens and implanted another lens from another manufacturer.There was no adverse event with the patient.Patient complained of glare, rim artifact.".

• Brand Name: SOFTEC HDM
• 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: 7377244
• Report Number: 9613160-2018-00017
• Device Sequence Number: 11133395
• Product Code: HQL
• UDI-Device Identifier: 00844369039338
• UDI-Public: 00844369039338
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: Health Professional
• Device Expiration Date: 05/17/2021
• Device Lot Number: 161307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1