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

Model Number	SOFTEC HDO
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After thorough investigation of the lens by the quality systems department, the results are as follows.Only one part of the optic was returned in the vial.All the packaging components except the delivery system and outer pouch were enclosed in the outer box.The inspection was performed at x30 magnification using a stereoscopic microscope.No foreign material was seen on the lens.The cross-section inspection of the optic piece was jagged.The remainder of the lens was not returned.The cartridge used was not returned for investigation but the lens model and diopter are compatible with the cartridge.This is the first complaint we have received relating to a lens 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 batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.Based on the lens inspection, lenstec is unable to make a conclusion as only part of the lens optic was returned for inspection.The jagged surface area suggested that the lens was cut with a sharp instrument.The lens and cartridge have been validated and proven compatible.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.
Event or Problem Description
A softec hdo lens was returned to lenstec with the notification stating "posterior capsular rupture, no patient injury".
Additional Manufacturer Narrative
After thorough investigation of the lens by the quality systems department, the results are as follows.Only one part of the optic was returned in the vial.All the packaging components except the delivery system and outer pouch were enclosed in the outer box.The inspection was performed at x30 magnification using a stereoscopic microscope.No foreign material was seen on the lens.The cross-section inspection of the optic piece was jagged.The remainder of the lens was not returned.The cartridge used was not returned for investigation but the lens model and diopter are compatible with the cartridge.This is the first complaint we have received relating to a lens 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 batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.Based on the lens inspection, lenstec is unable to make a conclusion as only part of the lens optic was returned for inspection.The jagged surface area suggested that the lens was cut with a sharp instrument.The lens and cartridge have been validated and proven compatible.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.
Event or Problem Description
A softec hdo lens was returned to lenstec with the notification stating "posterior capsular rupture, no patient injury".

• Brand Name: SOFTEC HDO
• 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: 5455617
• Report Number: 9613160-2016-00002
• Device Sequence Number: 1343965
• Product Code: HQL
• UDI-Device Identifier: 00844369037556
• UDI-Public: 00844369037556
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2016

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: 09/11/2017
• Device Model Number: SOFTEC HDO
• Device Lot Number: 123204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2016
• Supplement Report FDA Received Date: 02/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR