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

Model Number	GCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intraocular lens (iol) had a defect.Therefore, the surgeon cut it after implantation and implanted a new iol.Through follow-up, it was learned that there was a round approximately 1mm sized flaw on the optic that was seen during implantation.There was a 15 minute delay in the procedure, where the incision was enlarged, and the iol was removed and replaced with a new lens.No other medical interventions were necessary.The patient's pre operative visual acuity was 0.1 and the patient's post operative visual acuity was 0.1.No further information was provided.
Additional Manufacturer Narrative
Information unknown/ not provided.Per eu regulation 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(6).Initial reporter - first/given name: unknown/not provided.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.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 26th may 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the complaint lens was received inside of a specimen vial.No additional materials were received as part of this return.Visual inspection under magnification revealed that the lens was received cut in half (one half missing).The lens was cleaned, and no further issues could be identified with the lens.Based on the return condition of the lens, no further product evaluation could be performed.As a result of the investigation, there is no indication of a product quality deficiency.The complaint issue (dc-lens damaged) was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD
• 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: 14431168
• Report Number: 3012236936-2022-01259
• Device Sequence Number: 20440162
• Product Code: HQL
• UDI-Device Identifier: 05050474620636
• UDI-Public: (01)05050474620636(17)250201
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• 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): 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000215
• 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: 04/25/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Patient Sex: Female