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

Model Number	SOFTEC HD
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec (b)(4) received an e-mail notification stating that the lens was being returned.The lens was returned with the notification "explanted haptics moved into optical zone.Significant anterior capsular phimosis, dragging haptic into optic region".There was no patient injury and another lens was used.The lens was received in pieces in a plastic container; the container was labelled with the lens details and was enclosed in a biohazard bag.The lens was in five pieces.A visual examination was performed at 30x magnification using the stereoscopic microscope.The two haptics were intact as the cuts seen were done to the optic.The cross-sectional inspection of the pieces was jagged and as the lens was explanted, it is believed that the lens was cut up to facilitate this explanation.No other defects were noted.No discrepancies were found as it relates to the batch documentation analysis.The audit determined that all procedures in the manufacturing and packaging of the device had been carried out correctly.Batch reconciliation was 100%.Based on the lens inspection, the damage seen appeared to be deliberate cuts, probably to facilitate the removal of the lens from the eye.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.Additionally, the manner in which the lens was returned would not have passed our final clean and inspection operation.Furthermore, the assessment from the medical monitor stated that there was no way to conclusively blame the lens for the elective iol exchange.
Event or Problem Description
Significant anterior capsular phimosis, dragging haptic into optic region.

• 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: 7105425
• Report Number: 9613160-2017-00006
• Device Sequence Number: 13775535
• Product Code: HQL
• UDI-Device Identifier: 00844369027410
• UDI-Public: 00844369027410
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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 Model Number: SOFTEC HD
• Device Lot Number: 164714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1