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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Flashers (1864); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: weight and ethnicity: unknown/no information.If explanted; give date: not applicable, the iol has not been explanted.Device evaluated by mfr: the device is not returning for evaluation as indicated by the customer the lens remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report indicating that after implanting the intraocular lens (iol) into the patient's left eye, the patient experienced light streaks, halos and glare.A yag (yttrium-aluminum garnet) laser procedure was performed.The patient reported light streaks, glare and halos on (b)(6) 2021.However, he said he initially experienced symptoms one day post-op, (b)(6) 2021.The starbursts he reported around on (b)(6), after the laser procedure.During the implant surgery there were no complications, no sutures required, and no vitrectomy.Reportedly, there is likely nothing wrong with the iol and the lens remains implanted.No further information was provided.
Additional Manufacturer Narrative
Additional information through follow-up the customer explained the following.The right eye was implanted with a ray one iol (non-johnson and johnson) and the left eye was implanted with tecnis zcb00 - there is post-op residual refractive error in this eye and more corneal aberration.Patient has already had a yag capsulotomy done due to experiencing streaks of light and is still complaining of starburst.Surgeon has administered alphagan and just wanted to know what is causing the starburst.They discussed the aberrations of the cornea.No further information was provided.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 PR 00610
• MDR Report Key: 12046727
• Report Number: 2648035-2021-07903
• Device Sequence Number: 17167357
• Product Code: HQL
• UDI-Device Identifier: 05050474531611
• UDI-Public: (01)05050474531611(17)240803
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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