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

Lot Number	SB04294
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec received an e-mail notification stating "after the lens was already in the patient's eye the dr.Noticed the haptic was torn so he had to remove it.Another one of our lenses was used." 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 has been carried out correctly.Batch reconciliation was 100%.The lens was inspected under a stereoscopic microscope at 15x magnification.One haptic was completely missing.The returned piece (one intact haptic and optic) of the lens appeared smooth on the broken cross section area.This suggests that the haptic broke whilst in a dehydrated state.No foreign material or defects were seen on the lens.The cartridge and lens are compatible for implantation.Lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.The lens appeared to be handled whilst in a dehydrated state and this caused the break at the haptic.(b)(4).
Event or Problem Description
Lenstec, inc.Received an email notification stating "after the lens was already in patient's eye, the doctor noticed the haptic was torn so he removed it.Another lens of the same model and diopter used.".

• 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: 8262862
• Report Number: 9613160-2019-00002
• Device Sequence Number: 11282997
• Product Code: HQL
• UDI-Device Identifier: 00844369029506
• UDI-Public: 00844369029506
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/17/2019

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: 08/12/2023
• Device Lot Number: SB04294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1