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

Lot Number	171660
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	12/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Distributor reported the softec i iol appeared "hazy" under slit-lamp after operation, however, the lens remains implanted.Lenstec completed a batch review and no discrepancies were found as it relates to 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%.No other tests could be completed as the lens remains implanted.Once additional information about the event is obtained, a supplemental report will be filed.
Event or Problem Description
Iol reported to be "hazy" under slit lamp after operation.
Event or Problem Description
Iol reported to be "hazy" under slit lamp after operation.
Additional Manufacturer Narrative
Distributor reported the softec i iol appeared "hazy" under slit-lamp after operation, however, the lens remains implanted.Lenstec completed a batch review and no discrepancies were found as it relates to 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%.No other tests could be completed as the lens remains implanted.To perform a thorough investigation of the complaint, lenstec requested further information.However, (b)(6) was only able to provide information on one serial number and the serial number to which it pertained was unknown.There were no other lenses available from the reported batches in lenstec's inventory and no other complaints have been received with regards to these.Additionally, it was difficult to evaluate the complaint from the reported comments and the one slit lamp photograph was inconclusive.Lenstec's medical monitor was unable to ascertain any error from the photograph.Six lenses (fully shrink-wrapped and with the qc seal intact) from two of the reported batches were returned for inspection.Upon receipt of devices returned from the distributor, lenstec conducted a detailed microscopic investigation of the lenses.All packaging was intact and did not appear to have been opened or otherwise contaminated.All lenses were found to have a haze across them, which it was agreed by all staff would not have been accepted at final inspection.We have been unable to determine the source of the haze; however, we have determined that it is removable from the lens.These lenses are all part of the (b)(4) investigation.Additional devices were returned from the distributor and random samples were sent for cytotoxicity testing.The samples were submitted to (b)(4).Testing was conducted using two different methods: the l929 mem elution test and the l929 neutral red uptake test (1 concentration), performed in conformance with iso 10993-5:2009.The results indicated that the lenses meet all the specified requirements and showed no cytotoxic properties.Conclusion: lenstec is unable to make any definitive statement as to the cause of the haze.However, based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lenses were conducted correctly.Additionally, the cytotoxicity results showed no cytotoxic properties and lenstec can confirm that we have never had any confirmed lens-related cases relating to post-operative clouding, discolouration or opacification for our hema lenses.

• 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: 7169993
• Report Number: 9613160-2018-00003
• Device Sequence Number: 1357224
• Product Code: HQL
• UDI-Device Identifier: 00844369029544
• UDI-Public: 00844369029544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: Physician
• Device Expiration Date: 06/19/2022
• Device Lot Number: 171660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1