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

Model Number	ZCB00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section e1: reporter 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.Section h6: health effect - clinical code: 4581 pertains to both incision enlargement and device decentered or dislocated or tilted subluxated or wrong position.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that tecnis single piece monofocal intraocular lens (iol) was explanted as noticed lens tumbling/ unstable after injecting in bag.The pre-operative vision was 6/60.Lens inserted in the patients right eye and removed during same procedure.Incision was enlarged and vitrectomy was required.Additional information received revealed that the patient had no anatomical abnormalities.Customer used healon gv pro which is less viscous, so it would come out easily from bag when the iol was injected.Then while trying to positioning the iol in the bag, it was noted that the iol was tumbling and was not stable thus explanted.Lens was fully inserted and then removed and replaced with another competitor 3 piece iol during same procedure for sulcus support as no backup 3 piece tecnis was available in facility.No further information is available.

• Brand Name: TECNIS IOL
• 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: 17600474
• Report Number: 3012236936-2023-02137
• Device Sequence Number: 20373915
• Product Code: HQL
• UDI-Device Identifier: 05050474531765
• UDI-Public: (01)05050474531765(17)270301
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000225
• Was Device Available for Evaluation?: No
• 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: 07/26/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian