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

Lot Number	160517
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inspection was performed at x 10 magnification under a stereoscopic microscope.The lens was partially dehydrated.One haptic was intact while the other haptic was completely ripped from the lens.The area with the missing haptic was also badly damaged and appeared to have been caught in this area and torn.The damage extended to the lens optic and no other damage was noted.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 lenses had been conducted correctly.Batch reconciliation was 100.0%.After having carried out a detailed investigation of the lens in question, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the results of the visual examination, the lens appeared to have been damaged whilst being ejected, as the missing haptic area was caught and torn.However, lenstec can confirm that this lens would not have passed our final clean and visual inspection criteria and hence, would not have been released to the market.Additionally, lenstec is unable to comment on the suitability of the amo injection system used.Lenstec therefore recommends that the user follow the instructions for use provided with the lens which indicates the compatible instruments and the procedure for implantation of the lens.Lenstec believes the surgical complication experienced was not related to iol design or manufacturing.
Event or Problem Description
Lenstec received an email with the stated complaint "lens split in half during insertion, removed from eye, other softec i +32.0 implanted.Amo injection system.No patient injury or sutures".

• 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: 7346459
• Report Number: 9613160-2018-00016
• Device Sequence Number: 19009986
• Product Code: HQL
• UDI-Device Identifier: 00844369029780
• UDI-Public: 00844369029780
• 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): 03/16/2018

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: Physician
• Device Expiration Date: 03/18/2021
• Device Lot Number: 160517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1