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

Model Number	ZA9003
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Corneal Edema (1791); Vitreous Loss (2142)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact date of event is unknown.The best estimate is between (b)(6) 2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens was explanted from a patient's left eye due to corneal edema, vitreous prolapse and displacement of the lens.The incision was enlarged, vitrectomy was performed, and sutures were required.The date the symptoms first were noted is unknown.The patient was reported to be fine.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noted, that in the initial emdr report, 'other' was inadvertently selected for the section 'g1-2, contact office manufacturing site'.Which is incorrect, as that field should have been left empty.It was also noted, that section 'e1, establishment name' was inadvertently not populated in the initial emdr report.Therefore, the information has been captured in this supplemental emdr report.The following field was updated accordingly: section e1: establishment name: (b)(6) additional information: section d9: device available for evaluation? yes.Returned to manufacturer on: feb 4, 2021.Section h3: device evaluated by manufacturer? yes.Device evaluation: the sample was received at the manufacturing site for evaluation.Visual inspection under magnification revealed, fibers on the lens.However this can be attributed to receiving the lens wrapped in gauze.And therefore, cannot be confirmed to be related to manufacturing.The lens was cleaned, and no cosmetic defects were observed.The complaint issue could not be confirmed.And no product deficiency could be identified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specifications.A search in complaint system revealed, no other complaints have been received for this production order number.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 & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco 00610
• MDR Report Key: 11122147
• Report Number: 2648035-2021-07005
• Device Sequence Number: 3966765
• Product Code: HQL
• UDI-Device Identifier: 05050474529113
• UDI-Public: (01)05050474529113(17)170414
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 04/14/2017
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention