MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. CLARIFLEX; INTRAOCULAR LENS

Model Number	CLRFLXC
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the patient's eye due to blurry vision as a result of the iol being cloudy.The patient's reported visual acuity was 1.2.Postoperatively, the patient's vision was stated as being good with no problems.Sutures were required, but there was no reported health damage after surgery.The replacement iol model is unknown.No additional information was provided.
Additional Manufacturer Narrative
Section d6b: if explanted; give date: exact date unknown, estimated to be in (b)(6) 2023.Section e1: telephone number: (b)(6).Section h3-other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: september 7, 2023.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received wrapped in gauze.Product evaluation: visual inspection under magnification revealed the lens was received covered in a transparent substance.A white substance is also observed towards the center of the lens optic consistent with the complaint issue.Haptic damage is also observed.Based on the ftir results it was concluded that the lens should be cleaned and visual inspection performed.Brown specs could be observed inside of the lens material.Subject matter expert (sme) evaluation: the sme evaluation concluded that the markings in the lens are consistent with a yag laser treatment.Therefore, no further evaluation can be performed.A material analysis report was requested for the foreign material.Per the analysis, the bulk of the plastic material is a mixture, possibly composed of some or all of the following: polyethylene glycol (peg) oleate, another glycol derivative such as peg ether/ester, possibly a glycol tallowate (waxy soap), and other unidentified species.The ftir spectrum raw data output file generated was then compared against the manufacturing process ftir library and did not yield any results with at least a 0.90000 correlation.The top hit was ¿thermal transfer ribbon - matte side¿ with a 0.4940037 correlation.As a result of the investigation there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: CLARIFLEX
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16828089
• Report Number: 3012236936-2023-00987
• Device Sequence Number: 12543815
• Product Code: HQL
• UDI-Device Identifier: 05050474501461
• UDI-Public: (01)05050474501461
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: 12/31/2012
• Device Model Number: CLRFLXC
• Device Catalogue Number: CLRFLXC155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian