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

Lot Number	170943
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was received in the vial enclosed in a biohazard bag.The cap was on the vial, but the bung was absent.The delivery system and outer pouch were also absent, but the remainder of the packaging components was present.The inspection was performed at 15 x magnification using a stereoscopic microscope.The lens carried one heavy scratch on the optic.No other defects or foreign materials were seen on the lens.The dimension check conducted showed that the lens was 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 batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.The scratch seen on the optic appeared to be caused by handling due to the removal of the lens.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.Additionally, the complainant stated that it was not the lens specifically that caused the tear.
Event or Problem Description
Lenstec received an email stating "lens was inserted, patient had posterior capsular tear.Lens had to be placed in sulcus.Lens removed.Placed another lens and sutured in place.".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 7878111
• Report Number: 9613160-2018-00032
• Device Sequence Number: 18875433
• Product Code: HQL
• UDI-Device Identifier: 00844369027199
• UDI-Public: 00844369027199
• 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): 09/14/2018

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: 03/28/2022
• Device Lot Number: 170943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1