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

Model Number	CLRFLXC
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2 and a4: unknown; requested but not provided.Section b3: unknown; requested but not provided.Section d6a: if implanted; give date: unknown/not provided.Section e1: email address: unknown; requested but not provided.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.
Event or Problem Description
It was reported that the intraocular lens (iol) had opacified after implantation in the patient's eye.The iol was explanted due to blurry vision and a non-johnson & johnson iol was implanted.There was no reported patient injury.No additional information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: june 16, 2023.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The complaint lens was received inside of a specimen vial.No additional materials were received.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was evaluated with a white and black background.A thin film on the surface of the lens could be observed.Material analysis of the thin film was consistent with a heterogenous mixture, possibly composed of some or all of the following: inorganic salt species similar to sodium hyaluronate, polyethylene glycol (peg) oleate (e.G., surfactant, emulsifier, lubricant), another glycol derivative such as peg ether/ester, possibly a fatty acid glycol tallowate (surfactant, waxy soap), and another unidentified species.The fourier transform infrared (ftir) spectrum raw data output file was compared against the manufacturing process ftir library and did not yield any results with at least a 0.90000 correlation.The top hit for the first substance was ophthalmic viscoelastic device (ovd) evap with a correlation value of 0.8013928.The top hit for the second substance was ovd evap with a correlation value of 0.53420173.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.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: 17239227
• Report Number: 3012236936-2023-01563
• Device Sequence Number: 17943811
• Product Code: HQL
• UDI-Device Identifier: 05050474501454
• UDI-Public: (01)05050474501454
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 11/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: CLRFLXC
• Device Catalogue Number: CLRFLXC150
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2007
• 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